Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.

NCT02315768 | Completed Phase 1 Results DMC

• 1 other identifier: 141106
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether ibrutinib in combination with GA101 - Obinutuzumab might be useful for the treatment of CLL. This study will evaluate if ibrutinib in combination with GA101 - Obinutuzumab can reduce the amount of cancerous cells in body.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL; Chronic Lymphocytic Leukemia; Ibrutinib; Obinutuzumab; Cancer

Outcome Measures

Primary Outcomes (2)

• Safety, Tolerability and Dose Limiting Toxicity (DLT) of Ibrutinib in Combination With Obinutuzumab

  Remission rate after discontinuation of Ibrutinib in patients with previously untreated CLL treated with Ibrutinib in combination with Obinutuzumab

  4 weeks

• Overall Response Rate of Ibrutinib in Combination With Obinutuzumab

  Determine the overall response rate of Ibrutinib in combination with Obinutuzumab in previously untreated subjects with CLL. Overall response rate was based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2 years

Study Arms (1)

GA101+ibrutinib

EXPERIMENTAL

Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles. GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows: * Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered. * Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered. * Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered. * Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.

Drug: GA101; Drug: Ibrutinib

Interventions

GA101 DRUG

Also known as: Obinutuzumab

GA101+ibrutinib

Ibrutinib DRUG

Also known as: Imbruvica

GA101+ibrutinib

Eligibility Criteria

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

You may qualify if:

• Diagnosis of CLL
• Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines
• No previous treatment for CLL
• Males and females 65 years of age and older. Subjects under 65 years of age that meet any of the following criteria:
• A. Documented refusal to be treated with chemotherapy agents B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG g\>= 2), Cumulative Illness Rating Scale (CIRS score) \>= 6 or creatinine clearance less than 70 mL/min
• Adequate hematologic, hepatic, and renal function
• Anticipated survival of at least 6 months
• Effective contraception is required while receiving Ibrutinib in combination with GA101-Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101-Obinutuzumab and for 365 days (12 months) after the last dose of the study drug

You may not qualify if:

• Pregnant or nursing women
• Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
• Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Severe or debilitating pulmonary disease
• Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol.
• History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer.
• Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.
• Evidence of active acute or chronic Hepatitis B (HBV)
• Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to any of the study drugs
• Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes
• Vaccination with a live vaccine within 28 days of the initiation of treatment.
• Concomitant use of warfarin or other Vitamin K antagonists
• Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Sponsors & Collaborators

• University of California, San Diego: lead
• Pharmacyclics LLC.: collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Castro JE, Lengerke-Diaz PA, Velez Lujan J, Choi MY, Moreno-Cortes EF, Forero JV, Garcia-Robledo JE, Jacobs C, McCarthy C, Heinen A, Amaya-Chanaga CI, Kipps TJ. Ibrutinib plus Obinutuzumab as Frontline Therapy for Chronic Lymphocytic Leukemia Is Associated with a Lower Rate of Infusion-Related Reactions and with Sustained Remissions after Ibrutinib Discontinuation: A Single-Arm, Open-Label, Phase 1b/2 Clinical Trial NCT0231576. Adv Hematol. 2022 Jan 22;2022:4450824. doi: 10.1155/2022/4450824. eCollection 2022.

  PMID: 35103064 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms

Interventions

obinutuzumab; ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; 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

Results Point of Contact

• Title: Dr. Thomas Kipps
• Organization: UCSD

tkipps@ucsd.edu

858-534-5400

Study Officials

• Thomas J. Kipps, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: December 12, 2014
• Study Start: August 26, 2015
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

US (1)