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.
18 Years
N/A
Both
Lymphocytic Leukemia, Chronic
Trial Information
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.
Inclusion Criteria:
- Adults >/=18 years
- Documented CD20+B-CLL
- Previously untreated CLL requiring treatment according to the NCI criteria
- Total CIRS > 6 and/or creatinine clearance < 70 ml/min
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, and except for carcinoma in situ of the
cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate
cancer, or DCIS of the breast treated with lymphectomy alone
- Positive hepatitis serology (HBV, HCV) or positive HIV or HTLV testing
- Patients with active infection requiring systemic treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome 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
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: National Health and Medical Research Coincil
Study ID:
BO21004
NCT ID:
NCT01010061
Start Date:
December 2009
Completion Date:
May 2021
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Fountain Valley, California 92708 | |
| Baltimore, Maryland 21287 | |
| Milwaukee, Wisconsin |
