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Monoclonal Antibodies

Venetoclax + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Meghan Thompson, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Hemoglobin ≥ 8 g/dL without transfusion support, unless anemia is due to marrow involvement of CLL

Eastern Cooperative Oncology Group Performance Status of 0 or 1

Must not have

Recent major surgery (within 4 weeks prior to the start of Cycle 1, Day 1) other than for diagnosis

Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how well venetoclax and obinutuzumab work together to treat CLL in people who have not had prior treatment for their cancer.

Who is the study for?

Adults with untreated chronic lymphocytic leukemia who are generally in good health and have normal organ function. They must be able to perform daily activities with ease or only limited assistance (ECOG Performance Status of 0 or 1). Participants need to agree to use effective contraception and not donate sperm or eggs. People with a history of other cancers, significant infections, liver disease, positive tests for hepatitis B/C or HIV, recent major surgery, inability to swallow tablets, known drug allergies, or those requiring warfarin are excluded.

What is being tested?

The trial is testing the effectiveness of combining two drugs: Venetoclax and Obinutuzumab in treating CLL. The study includes adults who haven't been treated before for their cancer. It aims to gather more data on how well these drugs work together when given as an initial treatment.

What are the potential side effects?

Potential side effects from Venetoclax include diarrhea, nausea, low white blood cell count (neutropenia), upper respiratory tract infection, fatigue and pneumonia. Obinutuzumab may cause infusion reactions (symptoms related to the administration process), low blood cell counts leading to increased risk of infection or bleeding and potentially severe immune-mediated complications.

Eligibility Criteria

Inclusion Criteria

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

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My hemoglobin level is at least 8 g/dL without needing a blood transfusion.

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I am fully active or can carry out light work.

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My kidneys work well, with a filtration rate over 50 mL/min.

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I am fully active or can carry out light work.

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I agree to either not have sex or use birth control, and not donate sperm.

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I am 18 years old or older.

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I am 18 years old or older.

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My chronic lymphocytic leukemia has not been treated before.

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I am a woman who can still have children.

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I need treatment for my chronic lymphocytic leukemia according to specific guidelines.

Exclusion Criteria

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

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I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.

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I have been tested for hepatitis C; my PCR test is negative.

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I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.

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My CLL has changed into a more aggressive form of cancer.

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I do not have a significant history of liver disease.

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I am not taking strong or moderate drugs that affect liver enzyme CYP3A.

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I am not taking any strong or moderate drugs that speed up drug breakdown.

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I haven't had any live-virus vaccines in the last 28 days and won't need any during the study.

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I am not infected with HIV or HTLV-1.

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I need to take warfarin.

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.

Secondary study objectives

Overall response rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venetoclax and ObinutuzumabExperimental Treatment2 Interventions

All patients will receive a minimum of 9 cycles (cycle = 28 days) of therapy with venetoclax and obinutuzumab during the treatment period. For patients who remain MRD positive at Cycle 9 of therapy, an additional 12 cycles of venetoclax monotherapy will be given.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

Venetoclax

2019

Completed Phase 3

~2240