This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Clearview Cancer Institute
Huntsville, Alabama, United States
Highlands Oncology Group
Rogers, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
Cancer Center of Central Conn.
Southington, Connecticut, United States
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Kootenai Cancer Center
Coeur d'Alene, Idaho, United States
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, United States
...and 9 more locations
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Time frame: Cycles 1 to 6 (28-day cycles)
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
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.
Time frame: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
Number of Participants With Objective Response
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).
Time frame: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)
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