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Monoclonal Antibodies

Venetoclax + Obinutuzumab for Leukemia

Phase 3
Recruiting
Led By Deborah M Stephens
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is comparing the outcomes of starting treatment with venetoclax and obinutuzumab early versus starting treatment after symptoms appear, in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?
This trial is for adults diagnosed with high-risk CLL or SLL within the last year, who have not received prior CLL-directed therapy. They must have certain genetic markers, adequate organ function, and no active hepatitis B or C. Participants should be able to take oral medications and agree to quality of life assessments if they can complete forms in specified languages.Check my eligibility
What is being tested?
The study compares early versus delayed treatment using venetoclax (a medication that blocks a protein cancer cells need) and obinutuzumab (an antibody that helps the immune system fight cancer) in patients with newly diagnosed high-risk CLL/SLL to see which timing might lead to better outcomes.See study design
What are the potential side effects?
Venetoclax may cause diarrhea, nausea, low white blood cell counts increasing infection risk, fatigue, coughing. Obinutuzumab can cause infusion reactions like fever and chills, infections due to weakened immunity, low blood cell counts leading to bleeding/bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have an active hepatitis B or C infection, or if I have latent hepatitis B, I agree to take preventive treatment.
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I finished treatment for autoimmune issues from CLL over 4 weeks ago.
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I can take medicine by mouth.
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My genetic test results from a certified lab are less than a year old.
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I am 18 years old or older.
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My CLL has a high-risk score or complex genetic changes.
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I am taking no more than 20 mg/day of prednisone or its equivalent for a condition other than CLL/SLL.
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I can take care of myself and am up and about more than half of my waking hours.
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I do not have an active hepatitis B or C infection.
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I have never been treated with anti CD20 monoclonal antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Assessment of Cancer Therapy (FACT)-Leukemia total score
Overall survival
Secondary outcome measures
Event free survival
Incidence of adverse events
Overall Response rate
+4 more
Other outcome measures
FACT-Leukemia total score
Patient-reported health-related quality of life (HRQoL)
The individual components of the FACT-Leukemia

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (early V-O)Experimental Treatment7 Interventions
Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.
Group II: Arm I (delayed V-O)Active Control7 Interventions
Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Computed Tomography
2017
Completed Phase 2
~2720
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,607 Total Patients Enrolled
Deborah M StephensPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04269902 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: Arm I (delayed V-O), Arm II (early V-O)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT04269902 — Phase 3
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04269902 — Phase 3
Chronic Lymphocytic Leukemia Patient Testimony for trial: Trial Name: NCT04269902 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose do doctors usually prescribe Venetoclax?

"Venetoclax is an effective treatment option for small lymphocytic lymphoma, chronic lymphocytic leukemia (cll), and lymphoid leukemia."

Answered by AI

Are there other examples of Venetoclax's efficacy?

"In 2012, CHU de Dijon was the first to study venetoclax. Since then, there have been a total of 367 completed studies with 290 ongoing trials. The majority of these live studies are based in Seattle, Washington."

Answered by AI

Where are these clinical trials taking place?

"In total, this clinical trial is being conducted in 103 locations, with the three main sites being Swedish Medical Center-First Hill in Seattle, Washington, Crossroads Cancer Center in Effingham, Ohio, and Columbus Oncology and Hematology Associates Inc in Columbus, Texas."

Answered by AI

Are we still enrolling individuals in this test?

"Correct, the clinical trial is recruiting patients as of right now. The original posting was on December 14th, 2020, and the most recent update was on November 4th, 2022. They are looking for 247 patients total, which will be recruited from 100 different locations."

Answered by AI

What is the latest on Venetoclax's FDA approval process?

"While Phase 3 trials have less data supporting efficacy than later stage trials, there is still some evidence, and multiple rounds of data support Venetoclax's safety, so it receives a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Ohio
How old are they?
18 - 65
What site did they apply to?
Toledo Clinic Cancer Centers-Toledo
Regional Cancer Center at Indian Path Community Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have tried different kinda of drugs will work for me if i end up happen if in future.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
2021. "Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04269902.
All > Alaska > Chronic Lymphocytic Leukemia
~145 spots leftby Oct 2028
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