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Kinase Inhibitor

Ibrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

Led By Matthew Davids, MD, MMSc

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- ECOG Performance Status <2

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:

Must not have

- 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.

- Known bleeding disorders or hemophilia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combo therapy for Chronic Lymphocytic Leukemia (CLL).

Who is the study for?

Adults diagnosed with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who need treatment and have previously had therapy that didn't work. They must not be pregnant, agree to use contraception, and should not have severe allergies to monoclonal antibodies or a history of certain other cancers. Major organ functions must meet specific criteria, and they can't join if they've recently had surgery, infections requiring systemic treatment, heart issues, or are on strong CYP3A inhibitors.

What is being tested?

The trial is testing the effectiveness of combining two drugs: Ibrutinib and Obinutuzumab in treating Chronic Lymphocytic Leukemia (CLL). Participants will receive both medications as part of their treatment regimen to see how well they work together against CLL.

What are the potential side effects?

Possible side effects include allergic reactions related to infusion treatments, liver problems indicated by changes in enzyme levels, fatigue due to anemia or low blood counts from bone marrow involvement. There's also a risk for infection because the immune system may be weakened.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities without help.

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I have been diagnosed with CLL or SLL and need treatment.

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My blood tests show low hemoglobin or platelets.

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My spleen is very large, growing, or causing symptoms.

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I have lost more than 10% of my weight without trying in the last 6 months.

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I have had significant fatigue and fevers over 100.5°F without infection for 2+ weeks.

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My white blood cell count is at a safe level for treatment.

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I have had night sweats for over a month without being sick.

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My lymph nodes are very large, growing, or causing symptoms.

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My CLL has not responded or has come back after treatment.

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I am 18 years old or older.

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My autoimmune anemia or thrombocytopenia does not respond well to steroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.

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I have a bleeding disorder or hemophilia.

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I do not have HIV, active hepatitis C, or active hepatitis B.

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I have not had major surgery in the last 4 weeks.

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I do not have severe heart problems or recent major heart events.

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My cancer has spread to my brain or spinal cord.

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I need warfarin or similar drugs for blood thinning.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I do not have any ongoing infections that aren’t under control.

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I have been treated with obinutuzumab or ibrutinib before.

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My early-stage cancer was treated successfully with no signs of disease.

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I am not taking strong drugs that affect liver enzymes.

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I have not had a stroke or brain bleed in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Secondary study objectives

Complete Response Rate

Duration of Response

Minimal residual disease (MRD) status in the bone marrow and blood

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C- obinutuzumab/ibrutinibExperimental Treatment2 Interventions

Participants 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.

Group II: Arm B- ibrutinib -> obinutuzumabExperimental Treatment2 Interventions

Participants 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

Group III: Arm A- obinutuzumab -> ibrutinibExperimental Treatment2 Interventions

Participants 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Obinutuzumab

2014

Completed Phase 3

~3470