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

NCT02320487 | Completed Phase 2 Results

• 1 other identifier: ML29538
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 26

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines

  The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes \< 4 times 10\^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L, and hemoglobin \> 11.0 g/dL; normocellular BM aspirate with \< 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi.

  2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)

Secondary Outcomes (14)

• Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines

  2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)

• Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines

  From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)

• Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines

  Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)

• Overall Survival (OS)

  Day 1 until death from any cause (up to 46 months)

• Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow at Any Time During the Study

  Up to 46 months

Study Arms (1)

Obinutuzumab + Bendamustine (BG)

EXPERIMENTAL

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

Drug: Bendamustine; Drug: Obinutuzumab

Interventions

Bendamustine 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.

Also known as: Treanda, Levact

Obinutuzumab + Bendamustine (BG)

Obinutuzumab 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.

Also known as: GA101, Gazyva™, RO5072759

Obinutuzumab + Bendamustine (BG)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (26)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Southern Cancer Center - Mobile

Mobile, Alabama, 36608, United States

Location

Ironwood Cancer TX & Rsch Ctrs

Chandler, Arizona, 85224, United States

Location

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, 85284, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85704, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Rocky Mountain Cancer Center - Aurora

Aurora, Colorado, 80012, United States

Location

Cancer Care and Hematology

Fort Collins, Colorado, 80528, United States

Location

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

Location

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, 30060, United States

Location

Cancer Care & Hematology; Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, 46845, United States

Location

Center For Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Regional Cancer Care Associates LLC - Morristown

Morristown, New Jersey, 07962, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Northwest Cancer Specialists - Portland (N Broadway)

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, 97477, United States

Location

Texas Oncology-Arlington

Arlington, Texas, 76012, United States

Location

Texas Oncology-Tyler

Irving, Texas, 75063, United States

Location

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410, United States

Location

Cancer Care Centers of South Texas-HOAST - San Antonio

New Braunfels, Texas, 78130, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Related Publications (1)

• 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.

  PMID: 33243049 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; obinutuzumab

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)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  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: December 16, 2014
• First Posted: December 19, 2014
• Study Start: March 31, 2015
• Primary Completion: November 7, 2016
• Study Completion: February 6, 2019
• Last Updated: February 11, 2020
• Results First Posted: December 21, 2017

Record last verified: 2020-02

Locations

US (26)