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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02053610




Registration number
NCT02053610
Ethics application status
Date submitted
25/11/2013
Date registered
3/02/2014
Date last updated
14/09/2018

Titles & IDs
Public title
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
Scientific title
An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.
Secondary ID [1] 0 0
2009-012476-28; CLL1
Secondary ID [2] 0 0
BO21004 (Stage 2)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic 0 0
Condition category
Condition code
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 - obinutuzumab
Treatment: Drugs - rituximab
Treatment: Drugs - chlorambucil

Experimental: obinutuzumab + chlorambucil (GClb) - Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

Active comparator: rituximab + chlorambucil (RClb) - Participants received 375 mg/m\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).

Active comparator: Chlorambucil (Clb) - Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.


Treatment: Drugs: obinutuzumab
1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).

Treatment: Drugs: rituximab
375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6.

Treatment: Drugs: chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle
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
Randomization to clinical cutoff (median observation 59.4 months)
Primary outcome [2] 0 0
Percentage of Participants With Progression Free Survival Events
Timepoint [2] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [1] 0 0
Progression Free Survival Based on Independent Review Committee (IRC) Data
Timepoint [1] 0 0
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Secondary outcome [2] 0 0
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
Timepoint [2] 0 0
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Secondary outcome [3] 0 0
Percentage of Participants With End of Treatment Response (EOTR)
Timepoint [3] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [4] 0 0
Percentage of Participants With Best Overall Response
Timepoint [4] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [5] 0 0
Event Free Survival
Timepoint [5] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [7] 0 0
Duration of Response
Timepoint [7] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [8] 0 0
Percentage of Participants With Molecular Remission at the End of Treatment
Timepoint [8] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [9] 0 0
Time to Re-Treatment/New Anti-leukemic Therapy
Timepoint [9] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [10] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Timepoint [10] 0 0
Baseline and Cycle 4 Day 1 (Cy4D1)
Secondary outcome [11] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire
Timepoint [11] 0 0
Baseline and Cycle 4 Day 1 (Cy4D1)

Eligibility
Key inclusion criteria
* Adults >/=18 years
* Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
* Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
* Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior CLL therapy
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone
* Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing
* Patients with active infection requiring systemic treatment.

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
31/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2017
Sample size
Target
Accrual to date
Final
787
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Liverpool
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Sydney
Recruitment hospital [7] 0 0
- Greenslopes
Recruitment hospital [8] 0 0
- Southport
Recruitment hospital [9] 0 0
- Woolloongabba
Recruitment hospital [10] 0 0
- Kurralta Park
Recruitment hospital [11] 0 0
- Frankston
Recruitment hospital [12] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
2139 - Sydney
Recruitment postcode(s) [7] 0 0
4120 - Greenslopes
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Illinois
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Maryland
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Austria
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Graz
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Innsbruck
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Wien
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GO
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MG
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RS
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Brazil
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SP
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Bulgaria
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Pleven
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Plovdiv
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Bulgaria
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Sofia
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Varna
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Aalborg
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Odense
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Vejle
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Denmark
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Århus
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Egypt
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Cairo
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Reims
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Tours
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Vandoeuvre Les Nancy
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Ahaus
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Ansbach
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Bamberg
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Berlin
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Bonn
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Bremen
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Delitzsch
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Detmold
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Dresden
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Duisburg
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Erlangen
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Eschweiler
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Essen
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Esslingen
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Frankfurt am Main
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Frechen
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Freiburg
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Giessen
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Greifswald
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Koeln
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Kronach
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Landshut
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Leer
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Lörrach
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Lüdenscheid
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Magedburg
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Mainz
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Mannheim
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Muenchen
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Mutlangen
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München
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Nürnberg
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Oldenburg
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Porta Westfalica
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Ravensburg
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Trier
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Tübingen
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Ulm
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Germany
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Villingen-Schwenningen
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Weilheim
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Wendlingen
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Germany
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Witten
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Worms
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Germany
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Wuerzburg
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Würzburg
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Hong Kong
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Italy
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Italy
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Umbria
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Mexico
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Aguascalientes
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Mexico
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Culiacan
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Mexico
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Hermosillo
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Monterrey
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Mexico
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San Luis Potosi
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Netherlands
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Delftzijl
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Enschede
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Leeuwarden
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Nieuwegein
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Targu-mures
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Russian Federation
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Kazan
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Nizhny Novgorod
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Perm
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LA Coruña
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Navarra
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Valencia
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Jaen
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Las Palmas
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Madrid
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Malaga
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Murcia
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Salamanca
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Sevilla
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Toledo
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Spain
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Zaragoza
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Switzerland
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Aarau
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Luzern
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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United Kingdom
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Bournemouth
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United Kingdom
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Cambridge
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United Kingdom
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Canterbury
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United Kingdom
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Cardiff
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United Kingdom
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Cottingham
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German CLL Study Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Genentech, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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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/NCT02053610