CLL11: A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Phase 1
- Conditions
- Patients with previously untreated B-CLL with comorbidities.MedDRA version: 20.0Level: LLTClassification code 10003946Term: B-Lymphocytic, CLL (Kiel Classification)System Organ Class: 100000013108Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-012476-28-AT
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 786
Inclusion Criteria
1. Adult patients, aged 18 years or older
2. Have documented CD20+ B-CLL
3. Previously untreated CLL requiring treatment according to the NCI criteria (Hallek,M; Blood 2008)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 262
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 524
Exclusion Criteria
1. Prior CLL therapy
2. Transformation of CLL to aggressive NHL (Richter’s transformation)
3. History of other malignancy unless the malignancy has been in remission without treatment for = 2 years prior to enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in previously untreated CLL patients with comorbidities. ;Secondary Objective: • To evaluate PFS based on IRC<br>• To evaluate PFS censoring pts who started new anti-leukemic therapy before showing signs of disease progression<br>• To evaluate and compare in each arm: OR rate, CR and PR after the end of treatment, best OR rate within 6m of end of treatment, event-free survival, disease-free survival in CR/CRi patients, and duration of response in CR/CRi and PR pts<br>(for more details please see the study protocol);Primary end point(s): 1. Progression-free survival ;Timepoint(s) of evaluation of this end point: 2. Assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival<br>2. Molecular remission: minimal residual disease (MRD)<br>3. Safety profile: AEs, laboratory parameters <br>4. Pharmacokinetics of RO5072759 in combination with Clb <br>5. Patient-reported outcomes and symptom burden by EORTC questionnaire;Timepoint(s) of evaluation of this end point: 1. Assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up<br>2. Assessed after 3 cycles and 1,3,6 and 12 months after end of treatment<br>3. Monitored throughout study, laboratory assessments every 2 weeks on study treatment, 28 days after last dose and at intervals during follow-up<br>4. Pre- and post-dose sampling on day 1 of cycles 1-6<br>5. After 3 cycles, 28 days after last dose and at intervals during follow-up