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Chronic Lymphocytic LeukemiaPhase 1NCT02537613

A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase 1 study testing Obinutuzumab and Ibrutinib in people with Chronic Lymphocytic Leukemia, run by Dana-Farber Cancer Institute at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Obinutuzumab and Ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesUnited States
Study dates
Dec 2015to Jan 2027
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma as per IW-CLL 2008 criteria and require therapy based on meeting at least one of the following criteria:
  • Evidence of progressive marrow failure with anemia (hemoglobin <11.0 g/L) and/or thrombocytopenia (platelets <100 x 10^9/L)
  • Massive (≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly
  • Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy
  • Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of <6 months.
  • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids
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  • Constitutional symptoms, defined as 1 or more of the following:
  • unintentional weight loss >10% within 6 months prior to screening
  • significant fatigue (inability to work or perform usual activities) fevers >100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection
  • night sweats for more than 1 month prior to screening without evidence of infection
  • Relapsed after or refractory to at least one prior Chronic Lymphocytic Leukemia-directed therapy
  • Age greater than or equal to 18 years
  • ECOG Performance Status <2
  • Heme criteria at screening, unless significant bone marrow involvement of Chronic Lymphocytic Leukemia confirmed on biopsy:
  • Absolute Neutrophil Count (ANC) ≥500 cells/mm3 (0.5 x 10^9/L). Growth factor allowed to achieve
  • Platelet count ≥25,000 cells/mm3 (25 x 10^9/L) independent of transfusion within 7 days of screening
  • Adequate hepatic function defined as: AST and ALT ≤ 4.0 x upper limit of normal (ULN), bilirubin ≤2.0 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome)
  • Adequate renal function defined by serum creatinine <2.0 x upper limit of normal (ULN) unless due to biopsy proven Chronic Lymphocytic Leukemia kidney infiltration
  • Women of child-bearing potential and men must agree to use adequate contraception
  • Patients who have undergone prior allo transplant are eligible provided that their transplant day 0 is > 6 months from their first dose of study drug

Who cannot join

  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Prior treatment with either obinutuzumab or ibrutinib
  • History of other malignancies, except:
  • Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
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  • Low-risk prostate cancer on active surveillance
  • Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >20 mg/day of prednisone) within 28 days of the first dose of study drug.
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
  • Recent infection requiring systemic treatment that was completed ≤7 days before the first dose of study drug.
  • Known bleeding disorders or hemophilia.
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Known history of HIV or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Any uncontrolled active systemic infection.
  • Major surgery within 4 weeks of first dose of study drug.
  • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 CHF as defined by the NYHA Functional Classification; or a history of Myocardial Infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
  • Lactating or pregnant.
  • Patients receiving any other study agents
  • Patients with known Central Nervous System involvement
  • Baseline QT Interval Corrected by the Fridericia Correction Formula (QTcF) >480 ms unless Left Bundle Branch Block
  • Patients who require warfarin or other vitamin K antagonists for anticoagulation
  • Concurrent administration of strong inhibitors or inducers of CYP3A

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Rochester Wilmot Cancer Inst.

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase Ib Study of Ibrutinib in Combination With Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

Read the detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the best order of administration of these two drugs. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has approved ibrutinib and obinutuzumab individually for the treatment of patients with Chronic Lymphocytic Leukemia, your type of cancer. However, the FDA has not approved the combination of these two drugs as a treatment for any disease.

Ibrutinib is a type of drug called a kinase inhibitor. It is believed to block a type of protein called a kinase that helps leukemia cells live and grow. By blocking this, it is possible that the study drug will kill cancer cells or stop them from growing.

Obinutuzumab is a type of drug called a monoclonal antibody. It is believed to attach to a protein called CD20 on the outside of a Chronic Lymphocytic Leukemia cell. By attaching to the cell, the antibody can cause the Chronic Lymphocytic Leukemia cell to die.

In this research study, the investigators are assessing the safety of various dosing regimens of ibrutinib and obinutuzumab. The investigators are trying to determine whether it is better to give one drug before the other or if they can be started at the same time.

Being tested
Obinutuzumab, Ibrutinib
Keywords
Chronic Lymphocytic Leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • ObinutuzumabDrug

    Also called Gazyva, GA-101

    Obinutuzumab given weekly during cycle 1, then monthly during cycles 2-6

  • IbrutinibDrug

    Also called Imbruvica

    Ibrutinib given once daily by mouth

Study groups in NCT02537613
Study groupRoleWhat they receive
Arm A- obinutuzumab -> ibrutinibExperimentalParticipants enrolled in Arm A will receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6. Participants will begin to take ibrutinib daily starting cycle 2 and will continue with daily ibrutinib until the end of treatment.
Receives: Drug: Obinutuzumab; Drug: Ibrutinib
Arm B- ibrutinib -> obinutuzumabExperimentalParticipants enrolled in Arm B will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. Participants will begin to receive obinutuzumab weekly starting cycle 2, and will receive obinutuzumab monthly during cycles 3-7
Receives: Drug: Obinutuzumab; Drug: Ibrutinib
Arm C- obinutuzumab/ibrutinibExperimentalParticipants enrolled in Arm C will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. At the same time, participants will begin to receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6.
Receives: Drug: Obinutuzumab; Drug: Ibrutinib

What is being measured

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

  1. Grade 3-5 Treatment-related Toxicity Rate

    All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.

    Measured: AE evaluated at cycle 1 day day 1, 2, 8 and 15; cycle 2 day 1, 8, 15 and 22; then each cycle day 1 until end of treatment.

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.

    Measured: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.

  2. Partial Response Rate (PRR)

    The PRR was defined as the proportion of participants achieving partial response (PR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.

    Measured: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.

  3. Complete Response Rate (CRR)

    The CRR was defined as the proportion of participants achieving complete response (CR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.

    Measured: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.

  4. Minimal Residual Disease (MRD) Rate

    MRD rate was defined as the proportion of participants achieving MRD in bone marrow

    Measured: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD).

  5. Median Progression-Free Survival (PFS)

    Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.

    Measured: Through final follow-up visit (up to 9.63 years).

Timeline

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

  1. First posted1 Sep 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2020
  4. Study completionJan 2027 (estimated)

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537613
Sponsor's protocol ID
15-283
Status last verified
Sep 2026
First submitted
27 Aug 2015
Last updated
22 Sep 2026
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Obinutuzumab and Ibrutinib in people with Chronic Lymphocytic Leukemia, run by Dana-Farber Cancer Institute at 4 sites 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 20 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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.

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 22 Sep 2026). 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?

Grade 3-5 Treatment-related Toxicity Rate (time frame: AE evaluated at cycle 1 day day 1, 2, 8 and 15; cycle 2 day 1, 8, 15 and 22; then each cycle day 1 until end of treatment.). 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 NCT02537613.

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 22 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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