An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT01868893 | Completed Phase 2 Results

• 1 other identifier: ML28979
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 19

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.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Cycles 1 to 6 (28-day cycles)

Secondary Outcomes (2)

• 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

  Up to 28 days after the last dose of study drug (up to 7 months from Day 1)

• Number of Participants With Objective Response

  Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)

Study Arms (1)

Obinutuzumab + Chlorambucil

EXPERIMENTAL

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).

Drug: Obinutuzumab; Drug: Chlorambucil

Interventions

Obinutuzumab DRUG

Also known as: RO 5072759, GA101

Obinutuzumab + Chlorambucil

Chlorambucil DRUG

Obinutuzumab + Chlorambucil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (19)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, 94523, United States

Location

Cancer Center of Central Conn.

Southington, Connecticut, 06489, United States

Location

Peachtree Hematology & Oncology Consultants, Pc

Atlanta, Georgia, 30318, United States

Location

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, 30060, United States

Location

Kootenai Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Illinois Cancer Care, P.C. - Galesburg

Galesburg, Illinois, 61401, United States

Location

Joliet Oncology Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Mark H. Zangmeister Center

Columbus, Ohio, 43219, United States

Location

Charleston Hematology Oncology

Charleston, South Carolina, 29414, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Vince Lombardi Cancer Clinic Pharmacy

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

obinutuzumab; Chlorambucil

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 5, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 17, 2017
• Results First Posted: November 7, 2016

Record last verified: 2017-03

Locations

US (19)