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Bcl-2 Inhibitor

Venetoclax + Vincristine for Acute Lymphoblastic Leukemia

Phase 1 & 2

Waitlist Available

Led By Neil D Palmisiano

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

History of any lymphoproliferative disorder

Patients with poorly controlled human immunodeficiency virus (HIV), or CD4 < 400

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of venetoclax and vincristine liposomal on patients with T-cell or B-cell acute lymphoblastic leukemia.

Who is the study for?

This trial is for adults with T-cell or B-cell acute lymphoblastic leukemia that has returned or isn't responding to treatment. Participants must not be pregnant, should use effective contraception, and have no severe active infections like poorly controlled HIV. They shouldn't have other serious medical conditions that could affect participation, nor a history of certain cancers unless cured over 5 years ago. Recent chemotherapy recipients and those with high-grade peripheral neuropathy are excluded.

What is being tested?

The study is testing the combination of venetoclax, which blocks enzymes cancer cells need to grow, and vincristine liposomal, a chemotherapy drug that kills or stops cancer cells from dividing. The goal is to find the best dose of venetoclax and see if this combo works better for relapsed or refractory acute lymphoblastic leukemia.

What are the potential side effects?

Potential side effects include risks typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts; plus specific ones related to venetoclax like diarrhea and potential liver issues.

Eligibility Criteria

Inclusion Criteria

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

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My liver tests are within normal limits.

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I am able to care for myself and perform daily activities.

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I do not have severe heart issues like advanced heart failure or uncontrolled chest pain.

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My kidney function is good, with a creatinine clearance of at least 50 mL/min.

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My cancer has not spread to my brain or testicles.

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I do not have Burkitt's lymphoma/leukemia.

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I am not pregnant or breast-feeding.

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My leukemia has returned or didn't respond to treatment, with more than 5% cancer cells in my bone marrow.

Exclusion Criteria

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

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I have a history of disorders related to lymphocyte proliferation.

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My HIV is not well-controlled, or my CD4 count is below 400.

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I have a history of cancer.

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I have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Complete remission (CR) + complete remission incomplete (CRi) rate (Phase II)

Incidence of toxicities (Phase I)

Maximum tolerated dose of venetoclax (Phase I)

Secondary study objectives

Change in intracellular BCL-2 expression (Phase II)

Incidence of toxicities (Phase II)

Overall survival (OS) (Phase II)

+1 more

Other study objectives

BH3 profile (Phase II)

Expression of BCL-2 (Phase II)

Genetic signature (Phase II)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase Ib (venetoclax, vincristine liposomal)Experimental Treatment6 Interventions

Patients receive venetoclax PO QD on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.

Group II: Phase II (venetoclax, vincristine liposomal/sulfate)Experimental Treatment7 Interventions

Patients receive venetoclax PO QD on days 1-28 of each cycle. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks on day 1 of each cycle or vincristine sulfate IV weekly on days 1, 8, 15, and 22 of cycle 1 and once every 4 weeks on day 1 of each subsequent cycle. Cycles repeat every 28 days. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Lumbar Puncture

2016

Completed Phase 3

~510