Clinical trial NCT01868893: An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Official title: An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
* Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
* Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
* Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
* Life expectancy of \> 6 months

Exclusion Criteria:

* Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
* Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to chlorambucil or any of its excipients
* History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
* Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus 1 (HTLV-1) seropositive status
* Positive hepatitis serology
* Women who are pregnant or lactating
* Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
* Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for \>= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
* Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1

Primary outcomes:
measure: Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
timeFrame: Cycles 1 to 6 (28-day cycles)
Secondary outcomes:
measure: 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
timeFrame: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
measure: Number of Participants With Objective Response
timeFrame: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Southington
country: United States
facility: Cancer Center of Central Conn.
state: Connecticut
city: Atlanta
country: United States
facility: Peachtree Hematology & Oncology Consultants, Pc
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC - Marietta
state: Georgia
city: Coeur D'Alene
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Galesburg
country: United States
facility: Illinois Cancer Care, P.C. - Galesburg
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Ltd.
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Goshen
country: United States
facility: Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Columbus
country: United States
facility: Mark H. Zangmeister Center
state: Ohio
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Green Bay
country: United States
facility: Vince Lombardi Cancer Clinic Pharmacy
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: