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Chronic Lymphocytic LeukemiaPhase 1/2NCT02315768

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

A Phase 1/2 study testing GA101 and Ibrutinib in people with Chronic Lymphocytic Leukemia, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
GA101 and Ibrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
26 Aug 2015to 18 Apr 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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:
  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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
  • Chronic liver disease with hepatic impairment (Child-Pugh class B or C)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Ibrutinib in Combination With GA101 - Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients Over 65 Years of Age or With Comorbidities That Preclude the Use of Chemotherapy Based Treatment

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.

Read the detailed description

This is an open label phase IB/II clinical trial designed to determine the safety and clinical activity of Ibrutinib in combination with GA101 - Obinutuzumab. Safety, tolerability and dose-limiting toxicities (DLTs) will be evaluated during the initial cycle of treatment (Cycle 1; Day 1-28) as part of the phase Ib of this study (safety run-in).

In the phase II the response rate will be determined in all subjects that have received treatment. The study will enroll 32 subjects previously untreated who have active disease requiring treatment (as defined by IWCLL 2008 criteria for initiation of therapy). The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Screening Phase assessments will be performed within 28 days prior to treatment. The Treatment Phase will extend from first dose until completion of all planned cycles of treatment (#6) or study drug discontinuation.

All subjects will receive Ibrutinib 420 mg (3 x 140-mg capsules) orally once daily for up to 6 cycles. The treatment with Ibrutinib will continue after cycle 6 for the following 3 years until disease progression, unacceptable toxicity or other reason for treatment discontinuation.

Subjects will undergo response assessment two months after completion of the study treatment. The initial follow-up evaluations will be made (after the response assessment) every 3 months during 9 months and later every 6 months until initiation of new treatment for CLL, consent withdrawal or death. During the long-term follow-up phase, subjects will be followed for survival (PFS, TFS and OS). The long-term follow-up phase will continue until disease progression, death, loss to follow up, consent withdrawal, or study end, whichever occurs first.

An evaluation of the End of Study will be performed due to initiation of new treatment for CLL or withdrawal of consent.

Being tested
GA101, Ibrutinib
Keywords
CLL, Chronic Lymphocytic Leukemia, Ibrutinib, Obinutuzumab, Cancer
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GA101Drug

    Also called Obinutuzumab

  • IbrutinibDrug

    Also called Imbruvica

Study groups in NCT02315768
Study groupRoleWhat they receive
GA101+ibrutinibExperimentalIbrutinib 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.
Receives: Drug: GA101; Drug: Ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

  2. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2014 (estimated)
  2. Study start26 Aug 2015
  3. Primary completion18 Apr 2022
  4. Study completion18 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02315768
Sponsor's protocol ID
141106
Status last verified
Aug 2025
First submitted
30 Oct 2014
Last updated
15 Sep 2025
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35103064

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GA101 and Ibrutinib in people with Chronic Lymphocytic Leukemia, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety, Tolerability and Dose Limiting Toxicity (DLT) of Ibrutinib in Combination With Obinutuzumab (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02315768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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