A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
A Randomized Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia
2 other identifiers
interventional
357
7 countries
84
Brief Summary
This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2010
Longer than P75 for phase_4
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
June 25, 2015
CompletedJune 25, 2015
June 1, 2015
4 years
January 25, 2010
June 2, 2015
June 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy
The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (\<) 4 times 10\^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (\>/=) 1.5 times 10\^9 cells/L, platelets greater than (\>) 100 times 10\^9 cells/L, and hemoglobin \> 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with \< 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.
At least 2 months after completion of therapy (up to 32 weeks)
Secondary Outcomes (19)
Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy
At least 2 months after completion of therapy (up to 32 weeks)
Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy
At least 2 months after completion of therapy (up to 32 weeks)
Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation
After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection
Percentage of Participants by Disease Response Category in the First-Line Subpopulation
After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks)
Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation
End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)
- +14 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Eligibility Criteria
You may qualify if:
- adult patients, \>/=18 years of age
- chronic lymphocytic leukemia
- active CLL with progressive Binet stage B or C
- ineligible for treatment with fludarabine
- for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
- EOCG performance status \>/=2
You may not qualify if:
- patients who have relapsed within \<12 months of first dose of prior rituximab or chlorambucil first-line therapy
- previous or planned stem cell transplantation
- radioimmunotherapy within 6 months prior to starting study treatment
- transformation to aggressive B-cell malignancy
- any other concurrent anti-cancer therapy, or glucocorticoid \>/=20mg daily prednisolone or equivalent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Unknown Facility
Pori, 28500, Finland
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Vantaa, 01400, Finland
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Argenteuil, 95107, France
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Avignon, 84902, France
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Blois, 41016, France
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Bordeaux, 33076, France
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Brest, 29609, France
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La Roche-sur-Yon, 85925, France
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La Tronche, 38700, France
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Le Mans, 72037, France
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Lens, 62307, France
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Limoges, 87042, France
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Lyon, 69003, France
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Marseille, 13915, France
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Mulhouse, 68070, France
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Nice, 06202, France
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Nîmes, 30029, France
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Paris, 75571, France
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Paris, 75651, France
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Perpignan, 66046, France
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Pierre-Bénite, 69495, France
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Salouël, 80480, France
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Coimbra, 3000-075, Portugal
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Lisbon, 1099-166, Portugal
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Lisbon, 1600, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Vitoria-Gasteiz, Alava, 01009, Spain
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Elche, Alicante, 03203, Spain
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Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08907, Spain
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Barcelona, Barcelona, 08916, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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Torrelavega, Cantabria, 39300, Spain
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Huelva, Huelva, 21005, Spain
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A Coruña, La Coruña, 15006, Spain
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León, Leon, 24071, Spain
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Alcorcón, Madrid, 28922, Spain
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Madrid, Madrid, 28006, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28222, Spain
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Madrid, Madrid, 28905, Spain
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Málaga, Malaga, 29010, Spain
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Cartagena, Murcia, 30203, Spain
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Murcia, Murcia, 30008, Spain
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Murcia, Murcia, 30120, Spain
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Salamanca, Salamanca, 37007, Spain
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Seville, Sevilla, 41009, Spain
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Tarragona, Tarragona, 43007, Spain
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Valencia, Valencia, 46014, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Falun, 79182, Sweden
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Kristianstad, 29185, Sweden
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Luleå, S-971 80, Sweden
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Sundsvall, 85186, Sweden
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Uddevalla, 45180, Sweden
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Umeå, S-90185, Sweden
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Uppsala, 751 85, Sweden
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Tunis, 1008, Tunisia
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06500, Turkey (Türkiye)
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Ankara, 06620, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Edirne, 22050, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41400, Turkey (Türkiye)
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Samsun, 55139, Turkey (Türkiye)
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Blackpool, FY3 8NR, United Kingdom
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Bournemouth, BH7 7DW, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE5 9RS, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Manchester, OL1 2JH, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
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Romford, RM7 0AG, United Kingdom
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Somerset, TA1 5DA, United Kingdom
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Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 25, 2015
Results First Posted
June 25, 2015
Record last verified: 2015-06