An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT01868893|
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : November 6, 2016
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Obinutuzumab Drug: Chlorambucil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Obinutuzumab + Chlorambucil
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
Other Name: RO 5072759, GA101
- Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study [ Time Frame: Cycles 1 to 6 (28-day cycles) ]Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
- Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death [ Time Frame: Up to 28 days after the last dose of study drug (up to 7 months from Day 1) ]An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
- Number of Participants With Objective Response [ Time Frame: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1) ]Objective response is defined as either complete response [CR], complete response with incomplete recovery [CRi], or partial response [PR] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868893
|Study Director:||Clinical Trials||Genentech, Inc.|