Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01039376
Registration number
NCT01039376
Ethics application status
Date submitted
23/12/2009
Date registered
25/12/2009
Titles & IDs
Public title
Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
Query!
Scientific title
A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
Query!
Secondary ID [1]
0
0
COMB157C2301
Query!
Secondary ID [2]
0
0
112517
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PROLONG
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Leukaemia, Lymphocytic, Chronic
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Ofatumumab
Other interventions - Observation
Experimental: ARM A: Ofatumumab - 300 mg IV Week 1 followed by 1000 mg IV Week 2 1000 mg IV (a dose every 8 weeks for up to 2 years following the first 1000 mg dose)
Other: ARM B: Observation and assessments as per Arm A - Disease status assessments to determine subject response or progression performed approximately every 8 weeks for up to 2 years for both arms according to IWCLL criteria
Treatment: Other: Ofatumumab
Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.
Other interventions: Observation
Observation/Safety Evaluation
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival, as Assessed by the Investigator
Query!
Assessment method [1]
0
0
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.
Query!
Timepoint [1]
0
0
From randomization until progression or death (up to 79 months)
Query!
Primary outcome [2]
0
0
Progression-free Survival, as Assessed by the Independent Review Committee (IRC)
Query!
Assessment method [2]
0
0
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (\>1.5 centimeter \[cm\]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.
Query!
Timepoint [2]
0
0
From randomization until progression or death (up to 79 months)
Query!
Secondary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall survival is defined as time from randomization to date of death.
Query!
Timepoint [1]
0
0
From randomization until death (up to 88 months)
Query!
Secondary outcome [2]
0
0
Number of Participants With Improvement in Response From Baseline
Query!
Assessment method [2]
0
0
Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.
Query!
Timepoint [2]
0
0
From Baseline until the end of the study (up to 88 months)
Query!
Secondary outcome [3]
0
0
Time to Next Therapy
Query!
Assessment method [3]
0
0
Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.
Query!
Timepoint [3]
0
0
From randomization until the end of the study (up to 88 months)
Query!
Secondary outcome [4]
0
0
Progression-free Survival After Next-line Therapy
Query!
Assessment method [4]
0
0
Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.
Query!
Timepoint [4]
0
0
From randomization until progression or death (up to 88 months)
Query!
Secondary outcome [5]
0
0
Time to Progression After Next-line Therapy
Query!
Assessment method [5]
0
0
Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.
Query!
Timepoint [5]
0
0
From randomization until progression or death (up to 88 months)
Query!
Secondary outcome [6]
0
0
Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Query!
Assessment method [6]
0
0
The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single-item scales (social activities \[Social Problems (SP) Scale\] and future health worries \[Future Health (FH) Scale\]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).
Query!
Timepoint [6]
0
0
From randomization until the end of the study (up to 47 months)
Query!
Secondary outcome [7]
0
0
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Query!
Assessment method [7]
0
0
The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from "poor" (worse quality of life) to "excellent" (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA.
Query!
Timepoint [7]
0
0
From randomization until the end of the study (up to 47 months)
Query!
Secondary outcome [8]
0
0
Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale
Query!
Assessment method [8]
0
0
EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem\[s\] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.
Query!
Timepoint [8]
0
0
From screening until the end of the study (up to 47 months)
Query!
Secondary outcome [9]
0
0
Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points
Query!
Assessment method [9]
0
0
Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). Improvement in ECOG performance status was measured.
Query!
Timepoint [9]
0
0
From randomization until the end of the study (up to 88 months)
Query!
Secondary outcome [10]
0
0
Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points
Query!
Assessment method [10]
0
0
Participants with the indicated constitutional or B-symptoms (night sweats \[without signs of infection\]; unintentional weight loss \>= 10% within the previous 6 months; recurrent, unexplained fever of \> 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of participants with no night sweats, no weight loss, no fever and no extreme fatigue were summarized.
Query!
Timepoint [10]
0
0
From Screening until the end of the study (up to 88 months)
Query!
Secondary outcome [11]
0
0
Number of Participants With Grade 3 and Above Adverse Event of Infection
Query!
Assessment method [11]
0
0
Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).
Query!
Timepoint [11]
0
0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)
Query!
Secondary outcome [12]
0
0
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Query!
Assessment method [12]
0
0
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Query!
Timepoint [12]
0
0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)
Query!
Secondary outcome [13]
0
0
Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points
Query!
Assessment method [13]
0
0
Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia \[low hemoglobin count\], neutropenia \[low neutrophil count\], and thrombocytopenia \[low platelet count\]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
Query!
Timepoint [13]
0
0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)
Query!
Secondary outcome [14]
0
0
Number of Participants Who Received at Least One Transfusion During the Study
Query!
Assessment method [14]
0
0
Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.
Query!
Timepoint [14]
0
0
From randomization until the end of the study (up to 88 months)
Query!
Secondary outcome [15]
0
0
Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)
Query!
Assessment method [15]
0
0
AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.
Query!
Timepoint [15]
0
0
From randomization until the end of the study (up to 88 months)
Query!
Secondary outcome [16]
0
0
Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result
Query!
Assessment method [16]
0
0
All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.
Query!
Timepoint [16]
0
0
Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)
Query!
Secondary outcome [17]
0
0
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points
Query!
Assessment method [17]
0
0
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value.
Query!
Timepoint [17]
0
0
Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)
Query!
Secondary outcome [18]
0
0
Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit
Query!
Assessment method [18]
0
0
MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.
Query!
Timepoint [18]
0
0
From randomization until the end of the study (up to 88 months)
Query!
Secondary outcome [19]
0
0
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points
Query!
Assessment method [19]
0
0
CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Query!
Timepoint [19]
0
0
Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)
Query!
Secondary outcome [20]
0
0
Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers
Query!
Assessment method [20]
0
0
Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization \[FISH\]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio \<1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on \>=20%)=CY G.
Query!
Timepoint [20]
0
0
From Baseline until the end of the study (up to 79 months)
Query!
Secondary outcome [21]
0
0
Cmax and Ctrough of Ofatumumab
Query!
Assessment method [21]
0
0
Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.
Query!
Timepoint [21]
0
0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Query!
Secondary outcome [22]
0
0
Total Plasma Clearance (CL) of Ofatumumab
Query!
Assessment method [22]
0
0
Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.
Query!
Timepoint [22]
0
0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Query!
Secondary outcome [23]
0
0
AUC(0-tau) of Ofatumumab
Query!
Assessment method [23]
0
0
Area under the concentration time curve over the dosing interval (AUC\[0-tau\]) is a measure of the drug exposure over time.
Query!
Timepoint [23]
0
0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Query!
Secondary outcome [24]
0
0
Vss of Ofatumumab
Query!
Assessment method [24]
0
0
Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.
Query!
Timepoint [24]
0
0
Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)
Query!
Secondary outcome [25]
0
0
Plasma Half-life (t1/2) of Ofatumumab
Query!
Assessment method [25]
0
0
The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.
Query!
Timepoint [25]
0
0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Query!
Eligibility
Key inclusion criteria
* Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines (Hallek, 2008)
* At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment after the last dose of 2nd/3rd line treatment
* The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles
* ECOG Performance Status of 0-2
* Signed written informed consent prior to performing any study-specific procedures
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months
* Prior maintenance therapy
* Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL
* Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* Previous autologous or allogeneic stem cell transplantation
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C
* Other past or current malignancy (with the exception of basal cell carcinoma or the skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of exta systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
* History of significant cerebrovascular disease or event with symptoms or sequelae
* Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study
* Other anti-leukemic use of medications including glucocorticoids
* Known HIV positive
* Screening laboratory values: platelets <50 x 10x9/L, neutrophils<1.0 x 10x9/L, Creatinine > 1.5 X upper normal limit (unless normal creatinine clearance), total bilirubin >1.5 X upper normal limit, ALT >2.5 X upper normal limit (unless due to liver involvement of CLL), alkaline phosphase > 2.5 X upper normal limit
* Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation
* Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study
* Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/05/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/06/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
480
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Randwick
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Clayton
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - East Melbourne
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Santa Fe
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Antwerpen
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Brugge
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brussels
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Gent
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Hasselt
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Roeselare
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Wilrijk
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Bahía
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Goiás
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Rio Grande Do Sul
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
São Paulo
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Alberta
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Ontario
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Quebec
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Saskatchewan
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Brno
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Hradec Kralove
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Olomouc
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Pelhrimov
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Praha 10
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Herlev
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Kobenhavn
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Roskilde
Query!
Country [51]
0
0
Finland
Query!
State/province [51]
0
0
Helsinki
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Jyvaskyla
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Pori
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Tampere
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Turku
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Blois cedex
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Caen cedex 5
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Clermont-Ferrand Cedex 1
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Dijon
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Lille cedex
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Marseille Cedex 9
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Mulhouse
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Pessac cedex
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Saint Pierre cedex
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Strasbourg cedex
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Toulouse cedex 9
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Vandoeuvre-Les-Nancy
Query!
Country [68]
0
0
Greece
Query!
State/province [68]
0
0
Athens,
Query!
Country [69]
0
0
Greece
Query!
State/province [69]
0
0
Athens
Query!
Country [70]
0
0
Greece
Query!
State/province [70]
0
0
Piraeus
Query!
Country [71]
0
0
Greece
Query!
State/province [71]
0
0
Thessaloniki
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Budapest
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Debrecen
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Kecskemet
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Szeged
Query!
Country [76]
0
0
India
Query!
State/province [76]
0
0
Ahmedabad
Query!
Country [77]
0
0
India
Query!
State/province [77]
0
0
Mumbai
Query!
Country [78]
0
0
India
Query!
State/province [78]
0
0
Pune
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Afula
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Haifa
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Jerusalem
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Kfar Saba
Query!
Country [83]
0
0
Israel
Query!
State/province [83]
0
0
Nahariya
Query!
Country [84]
0
0
Israel
Query!
State/province [84]
0
0
Petach-Tikva
Query!
Country [85]
0
0
Israel
Query!
State/province [85]
0
0
Ramat Gan
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Rehovot
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Tel-Aviv
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Zrifin
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Emilia-Romagna
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Lazio
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Piemonte
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Toscana
Query!
Country [93]
0
0
Korea, Republic of
Query!
State/province [93]
0
0
Seoul
Query!
Country [94]
0
0
Netherlands
Query!
State/province [94]
0
0
Amersfoort
Query!
Country [95]
0
0
Netherlands
Query!
State/province [95]
0
0
Amsterdam
Query!
Country [96]
0
0
Netherlands
Query!
State/province [96]
0
0
Blaricum
Query!
Country [97]
0
0
Netherlands
Query!
State/province [97]
0
0
Breda
Query!
Country [98]
0
0
Netherlands
Query!
State/province [98]
0
0
Den Bosch
Query!
Country [99]
0
0
Netherlands
Query!
State/province [99]
0
0
Den Haag
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Deventer
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
Dordrecht
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Enschede
Query!
Country [103]
0
0
Netherlands
Query!
State/province [103]
0
0
Groningen
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Hoofddorp
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Leiden
Query!
Country [106]
0
0
Netherlands
Query!
State/province [106]
0
0
Maastricht
Query!
Country [107]
0
0
Netherlands
Query!
State/province [107]
0
0
Rotterdam
Query!
Country [108]
0
0
Netherlands
Query!
State/province [108]
0
0
Sittard-geleen
Query!
Country [109]
0
0
Netherlands
Query!
State/province [109]
0
0
Tilburg
Query!
Country [110]
0
0
Norway
Query!
State/province [110]
0
0
Oslo
Query!
Country [111]
0
0
Poland
Query!
State/province [111]
0
0
Bialystok
Query!
Country [112]
0
0
Poland
Query!
State/province [112]
0
0
Chorzow
Query!
Country [113]
0
0
Poland
Query!
State/province [113]
0
0
Slupsk
Query!
Country [114]
0
0
Poland
Query!
State/province [114]
0
0
Szczecin
Query!
Country [115]
0
0
Poland
Query!
State/province [115]
0
0
Warszawa
Query!
Country [116]
0
0
Poland
Query!
State/province [116]
0
0
Wroclaw
Query!
Country [117]
0
0
Puerto Rico
Query!
State/province [117]
0
0
San Juan
Query!
Country [118]
0
0
Russian Federation
Query!
State/province [118]
0
0
Kazan
Query!
Country [119]
0
0
Russian Federation
Query!
State/province [119]
0
0
Moscow
Query!
Country [120]
0
0
Russian Federation
Query!
State/province [120]
0
0
Novosibirsk
Query!
Country [121]
0
0
Russian Federation
Query!
State/province [121]
0
0
Penza
Query!
Country [122]
0
0
Russian Federation
Query!
State/province [122]
0
0
St'Petersburg
Query!
Country [123]
0
0
Russian Federation
Query!
State/province [123]
0
0
St. Petersburg
Query!
Country [124]
0
0
Russian Federation
Query!
State/province [124]
0
0
Volgograd
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Hospitalet de Llobregat (Barcelona)
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Madrid
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Salamanca
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Sevilla
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Toledo
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Zaragoza
Query!
Country [131]
0
0
Sweden
Query!
State/province [131]
0
0
Goteborg
Query!
Country [132]
0
0
Sweden
Query!
State/province [132]
0
0
Linkoping
Query!
Country [133]
0
0
Sweden
Query!
State/province [133]
0
0
Lulea
Query!
Country [134]
0
0
Sweden
Query!
State/province [134]
0
0
Orebro
Query!
Country [135]
0
0
Sweden
Query!
State/province [135]
0
0
Stockholm
Query!
Country [136]
0
0
Sweden
Query!
State/province [136]
0
0
Uppsala
Query!
Country [137]
0
0
Turkey
Query!
State/province [137]
0
0
Ankara
Query!
Country [138]
0
0
Turkey
Query!
State/province [138]
0
0
Istanbul
Query!
Country [139]
0
0
Turkey
Query!
State/province [139]
0
0
Izmir
Query!
Country [140]
0
0
Ukraine
Query!
State/province [140]
0
0
Cherkasy
Query!
Country [141]
0
0
Ukraine
Query!
State/province [141]
0
0
Dnipropetrovsk
Query!
Country [142]
0
0
Ukraine
Query!
State/province [142]
0
0
Kharkiv
Query!
Country [143]
0
0
Ukraine
Query!
State/province [143]
0
0
Khmelnytskyi
Query!
Country [144]
0
0
Ukraine
Query!
State/province [144]
0
0
Kyiv
Query!
Country [145]
0
0
Ukraine
Query!
State/province [145]
0
0
Lviv
Query!
Country [146]
0
0
Ukraine
Query!
State/province [146]
0
0
Makiivka
Query!
Country [147]
0
0
Ukraine
Query!
State/province [147]
0
0
Vinnitsa
Query!
Country [148]
0
0
Ukraine
Query!
State/province [148]
0
0
Zhytomyr
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01039376
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/76/NCT01039376/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/76/NCT01039376/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01039376