CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/16/2018 |
| Start Date: | December 21, 2009 |
| End Date: | August 23, 2017 |
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.
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of
obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus
chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic
leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles
of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and
day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or
rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 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. In the US, this trial is
sponsored/managed by Genentech.
obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus
chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic
leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles
of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and
day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or
rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 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. In the US, this trial is
sponsored/managed by Genentech.
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on
clinicaltrials.gov because there are 3 separate primary analyses conducted at different
time-points.
- BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.
- BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus
chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
- BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported
separately.
clinicaltrials.gov because there are 3 separate primary analyses conducted at different
time-points.
- BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.
- BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus
chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
- BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported
separately.
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
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 lymphectomy
alone
- Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus
(HTLV) testing
- Patients with active infection requiring systemic treatment
We found this trial at
6
sites
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