A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

NCT ID: NCT02320487

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-02-06

Brief Summary

This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG induction therapy in participants with previously untreated CLL. The anticipated time on study treatment is 24 weeks.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obinutuzumab + Bendamustine (BG)

Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m\^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6.

Obinutuzumab

Intervention Type: DRUG

Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.

Interventions

Bendamustine

Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m\^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6.

Intervention Type: DRUG

Obinutuzumab

Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.

Intervention Type: DRUG

Other Intervention Names

Treanda; Levact; GA101; Gazyva™; RO5072759

Eligibility Criteria

Inclusion Criteria

• Participants must satisfy one of the criteria for treatment initiation, as outlined in the iwCLL NCI-WG guidelines. The criteria include: (a) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia, (b) Massive (i.e., greater than or equal to [>=] 6 centimeters [cm] below the left costal margin) or progressive or symptomatic splenomegaly, (c) Massive nodes (i.e., >= 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy, (d) Progressive lymphocytosis with an increase of greater than (>) 50 percent (%) over a 2-month period or lymphocyte doubling time (LDT) of less than (<) 6 months, (e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, (f) Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: unintentional weight loss of >=10% within the previous 6 months, significant fatigue (i.e., Eastern Cooperative Oncology Group Performance Status [ECOG PS] of 2 or worse or the inability to work or perform usual activities), fevers higher than 100.5 degrees Fahrenheit (°F)/38.0 degrees Celsius (°C) for >= 2 weeks without other evidence of infection, or night sweats for >1 month without evidence of infection
• Absolute neutrophil count (ANC) >=1.5 × 10^9 per liter (/L) and platelets >=75 × 10^9/L unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)
• Life expectancy >6 months
• ECOG PS of 0, 1, or 2
• Willing to use acceptable contraceptive measures as defined by the protocol during and at least for 6 months (male participants) or 12 months (female participants) after the last dose of study drug

Exclusion Criteria

• Pregnant or lactating, or intending to become pregnant during the study: Women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
• Participants who have received previous CLL therapy, including investigational therapies
• Transformation of CLL to aggressive non-Hodgkin's lymphoma (Richter's transformation)
• Inadequate renal function
• Inadequate liver function: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >5× upper limit of normal [ULN] for >2 weeks; bilirubin >3× ULN) unless due to underlying disease
• History of other malignancy, which could affect compliance with the protocol or interpretation of results
• Participants with active bacterial, viral, or fungal infection requiring systemic treatment
• Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1)
• Positive hepatitis serology: (a) Participants with positive serology for hepatitis B, defined as positivity for hepatitis B surface antigen (HBsAg), or participants who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive, (b) Participants positive for anti-HBc, but with negative hepatitis B Virus (HBV) deoxyribonucleic acid (DNA), will be considered for inclusion by the Medical Monitor on a case-by-case basis in order to ensure feasibility of monthly DNA testing and availability of appropriate care in case of hepatitis B reactivation, (c) Participants with positive serology for hepatitis C (HCV) unless HCV (by ribonucleic acid [RNA]) is confirmed negative
• History of severe allergic or anaphylactic reactions to monoclonal antibodies
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)
• Vaccination with a live vaccine a minimum of 30 days prior to study treatment
• Use of investigational agents of any kind within 30 days before study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Clearview Cancer Institute

Huntsville, Alabama, United States

Southern Cancer Center - Mobile

Mobile, Alabama, United States

Ironwood Cancer TX & Rsch Ctrs

Chandler, Arizona, United States

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, United States

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Rocky Mountain Cancer Center - Aurora

Aurora, Colorado, United States

Cancer Care and Hematology

Fort Collins, Colorado, United States

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Cancer Care & Hematology; Specialists of Chicagoland

Niles, Illinois, United States

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, United States

Center For Cancer and Blood Disorders

Bethesda, Maryland, United States

Regional Cancer Care Associates LLC - Morristown

Morristown, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Northwest Cancer Specialists - Portland (N Broadway)

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, United States

Texas Oncology-Arlington

Arlington, Texas, United States

Texas Oncology-Tyler

Irving, Texas, United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, United States

Cancer Care Centers of South Texas-HOAST - San Antonio

New Braunfels, Texas, United States

Northern Utah Associates

Ogden, Utah, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States

Countries

United States

References

Sharman JP, Burke JM, Yimer HA, Boxer MA, Babu S, Li J, Mun Y, Danilov AV; GIBB study investigators. Phase 2, multicenter GIBB study of obinutuzumab plus bendamustine in previously untreated patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2021 Apr;62(4):791-800. doi: 10.1080/10428194.2020.1850719. Epub 2020 Nov 26.

Reference Type: DERIVED

PMID: 33243049 (View on PubMed)

Other Identifiers

ML29538

Identifier Type: -

Identifier Source: org_study_id