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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01973387




Registration number
NCT01973387
Ethics application status
Date submitted
25/10/2013
Date registered
31/10/2013
Date last updated
24/07/2018

Titles & IDs
Public title
A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
Scientific title
A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 (Ibrutinib) Versus Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Secondary ID [1] 0 0
PCI-32765CLL3002
Secondary ID [2] 0 0
CR102604
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Ibrutinib

Experimental: Treatment Arm A -

Experimental: Treatment Arm B -


Treatment: Drugs: Rituximab
Up to 6 cycles (total of 8 doses administered by intravenous infusion): 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); and 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).

Treatment: Drugs: Ibrutinib
420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
From the date of randomization to disease progression (Up to 3.7 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From the date of randomization to the date of death (Up to 3.7 years)
Secondary outcome [3] 0 0
Number of Participants With Sustained Hematologic Improvement
Timepoint [3] 0 0
From the date of randomization to disease progression (Up to 3.7 years)
Secondary outcome [4] 0 0
Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms
Timepoint [4] 0 0
From the date of randomization to disease progression (Up to 3.7 years)

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group performance status of 0-1
* Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that meets protocol-defined criteria
* Laboratory values within protocol-defined parameters
* Active disease meeting International Workshop on Chronic Lymphocytic Leukemia 2008 criteria
* Received at least 1 prior therapy for CLL/SLL and not appropriate for treatment or retreatment with purine analog-based therapy
* Measurable nodal disease by computed tomography
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and agree to use highly effective methods of contraception during the study and for 90 days following the last dose with ibrutinib or 12 months following the last dose of rituximab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Central nervous system lymphoma or leukemia
* Prolymphocytic leukemia or history of or currently suspected Richter's transformation
* Refractory to prior rituximab-based therapy
* Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days prior to first dose of study drug
* Corticosteroid use >20 mg within 1 week prior to first dose of study drug
* Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose of study drug
* Prior autologous transplant within 6 months prior to first dose of study drug
* Prior allogeneic stem cell transplant
* Major surgery within 4 weeks prior to first dose of study drug
* History of prior malignancy according to protocol-defined criteria
* Currently active clinically significant cardiovascular disease within 6 months prior to first dose with study drug
* Uncontrolled active systemic fungal, bacterial, viral, or other ongoing anti-infective treatment administered intravenously
* History of human immunodeficiency virus or active infection with hepatitis B or C
* History of stroke or intracranial hemorrhage within 6 months prior to random assignment
* Pregnant or lactating women
* Current life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, or put the study at risk
* Requires or receiving anticoagulation with warfarin or equivalent Vitamin K antagonists
* Requires treatment with a strong CYP3A4/5 inhibitor
* Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (greater than [>]20 milligram [mg] daily of prednisone daily or equivalent)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/08/2017
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Tweed Heads
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Tweed Heads
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chendu
Country [3] 0 0
China
State/province [3] 0 0
Fuzhou
Country [4] 0 0
China
State/province [4] 0 0
Guangzhou
Country [5] 0 0
China
State/province [5] 0 0
Jinan
Country [6] 0 0
China
State/province [6] 0 0
Nanjing
Country [7] 0 0
China
State/province [7] 0 0
Qingdao
Country [8] 0 0
China
State/province [8] 0 0
Shanghai
Country [9] 0 0
China
State/province [9] 0 0
Suzhou
Country [10] 0 0
China
State/province [10] 0 0
Tianjin
Country [11] 0 0
China
State/province [11] 0 0
Unk Hangzhou
Country [12] 0 0
China
State/province [12] 0 0
Wuhan
Country [13] 0 0
China
State/province [13] 0 0
Xian
Country [14] 0 0
Malaysia
State/province [14] 0 0
Johor Bahru
Country [15] 0 0
Malaysia
State/province [15] 0 0
Kuala Lumpur
Country [16] 0 0
Malaysia
State/province [16] 0 0
Melaka
Country [17] 0 0
Malaysia
State/province [17] 0 0
Subang Jaya
Country [18] 0 0
Taiwan
State/province [18] 0 0
Changhua
Country [19] 0 0
Taiwan
State/province [19] 0 0
Kaohsiung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Tainan
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pharmacyclics LLC.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01973387