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Monoclonal Antibodies
Venetoclax + Obinutuzumab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Lindsey Roeker, 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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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:Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression-free survival (PFS)
Secondary outcome measures
Overall response rate
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
~1990
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,651 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
567,977 Total Patients Enrolled
Lindsey Roeker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
135 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 8 g/dL without needing a blood transfusion.My blood counts are within normal ranges, not affected by my condition.The ability and willingness to comply with the requirements of the study protocol.I had or have hidden hepatitis B but no active virus, and I agree to monthly DNA tests.I am fully active or can carry out light work.I have had treatment for CLL, but may have taken steroids for less than a week to manage symptoms.I had surgery for early-stage, low-grade prostate cancer and currently show no signs of the disease.Your overall health score, excluding your CLL diagnosis, is 6 or lower.You have a condition that affects how your body absorbs medicine through the digestive system. This will be decided by the doctor.I have been tested for hepatitis C; my PCR test is negative.Contraceptive methods that have a very low chance of failure (less than 1% per year) include tubal ligation, male sterilization, certain hormonal contraceptives that stop ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs.My cervical cancer was treated successfully and is no longer present.My kidneys work well, with a filtration rate over 50 mL/min.I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.My liver is working well.I understand and commit to reliable contraception methods during the trial.I understand and commit to reliable contraception methods during the trial.You have difficulty swallowing a lot of pills.My platelet count is at least 30, or at least 10 if my low count is due to bone marrow cancer.I had cancer before but have recovered from the treatment side effects.I agree to use highly effective birth control or remain abstinent during and after treatment.I will use highly effective birth control or remain abstinent during and after treatment as required.My CLL has changed into a more aggressive form of cancer.I do not have a significant history of liver disease.You have a known allergy or sensitivity to any of the study drugs.I was treated for cancer with the goal of cure and have had no active disease for 2 years.I haven't taken certain medications within a week before starting venetoclax.I am not taking strong or moderate drugs that affect liver enzyme CYP3A.I am not taking any strong or moderate drugs that speed up drug breakdown.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I am fully active or can carry out light work.I agree to either not have sex or use birth control, and not donate sperm.I haven't had any live-virus vaccines in the last 28 days and won't need any during the study.I am not infected with HIV or HTLV-1.I am 18 years old or older.I am 18 years old or older.My chronic lymphocytic leukemia has not been treated before.I am a woman who can still have children.I will use protection or remain abstinent during my partner's pregnancy to protect the baby.Your overall health score, called CIRS score, should be 6 or below (excluding the diagnosis of CLL).I need treatment for my chronic lymphocytic leukemia according to specific guidelines.I had skin cancer (not melanoma) or lentigo maligna, but it's now treated with no signs of the disease.I need to take warfarin.You have allergies to medications called xanthine oxidase inhibitors and rasburicase.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax and Obinutuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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