A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Tracking InformationStart Date ICMJE | |
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Primary Completion Date | |
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Current Primary Outcome Measures ICMJE (submitted: November 6, 2009) | Progression-free survival [ Time Frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT01010061 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: November 6, 2009) | - Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival [ Time Frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up ] [ Designated as safety issue: No ]
- Molecular remission: minimal residual disease (MRD) [ Time Frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
- Safety profile: AEs, laboratory parameters [ Time Frame: monitored throughout study, laboratory assessments every 2 weeks on study treatment, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]
- Pharmacokinetics of RO5072759 in combination with Clb [ Time Frame: pre- and post-dose sampling on day 1 of cycles 1-6 ] [ Designated as safety issue: No ]
- Patient-reported outcomes and symptom burden by EORTC questionnaire [ Time Frame: after 3 cycles, 28 days after last dose and at intervals during follow-up ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia |
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Official Title ICMJE | 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. |
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Brief Summary | This open-label, randomized, 3-arm study will evaluate the efficacy and safety of RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia. Patients will be randomized to receive a maximum of 6 cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2 cycle 1, 500mg/m2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. Target sample size is <800. In the US, this trial is sponsored/managed by Genentech. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Lymphocytic Leukemia, Chronic |
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Intervention ICMJE | - Drug: RO5072759
1000 mg by iv infusion, on days 1,8 and 15 in cycle 1, day 1 in cycles 2-6 - Drug: rituximab
by iv infusion on day 1 of each cycle, 375 mg/m2 cycle 1, 500 mg/m2 cycles 2-6 - Drug: chlorambucil
0,5 mg/kg orally on day 1 and 15 of each cycle
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Study Arms / Comparison Groups | |
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Recruitment InformationEstimated Enrollment ICMJE | 786 |
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Estimated Completion Date | January 2022 |
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Primary Completion Date | |
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Eligibility Criteria ICMJE | Inclusion Criteria: - adults >/=18 years
- documented CD20+B-CLL
- previously untreated CLL requiring treatment according to the NCI criteria
Exclusion Criteria: - prior CLL therapy
- transformation of CLL to aggressive NHL (Richter's transformation)
- history of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Romania, Russian Federation, Slovakia, Spain, Switzerland, Thailand, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT01010061 |
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Responsible Party | Disclosures Group, Hoffmann-La Roche |
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Study ID Numbers ICMJE | BO21004, 2009-012476-28 |
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Study Sponsor ICMJE | Hoffmann-La Roche |
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Collaborators ICMJE | Genentech |
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Investigators ICMJE | Study Director: | Clinical Trials | Hoffmann-La Roche | |
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Information Provided By | Hoffmann-La Roche |
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