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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

Must not have

Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura

Participants must not meet any of the IWCLL specified criteria for active CLL therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

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

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I do not have uncontrolled autoimmune blood disorders.

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I do not meet the criteria for active chronic lymphocytic leukemia treatment.

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I do not have serious heart problems like uncontrolled irregular heartbeat or severe heart failure.

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I do not have any known bleeding disorders.

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I am not on strong medication that affects venetoclax metabolism.

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I do not have cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

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

Primary study objectives

Functional Assessment of Cancer Therapy (FACT)-Leukemia total score

Overall survival

Secondary study objectives

Event free survival

Incidence of adverse events

Overall Response rate

+4 more

Other study objectives

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%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (early V-O)Experimental Treatment8 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 and biopsy throughout the trial.

Group II: Arm I (delayed V-O)Active Control8 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 and biopsy throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Biospecimen Collection

2004

Completed Phase 3

~2030