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Tyrosine Kinase Inhibitor

Hyper-CVAD + Venetoclax for Acute Leukemia

Phase 1

Waitlist Available

Led By David McCall, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Participants with CD19+ B-ALL need to have received CD19-directed therapy prior to being considered for enrollment on this study

Must not have

Liver cirrhosis or other active severe liver disease or with suspected active alcohol abuse

Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine the safe and effective dose of a combination treatment for people with leukemia that has returned or not responded to previous treatments."

Who is the study for?

This trial is for pediatric patients with certain types of leukemia that have come back or didn't respond to previous treatments. These leukemias include acute undifferentiated, mixed phenotype, and others of the lymphoid lineage.

What is being tested?

The study aims to determine the appropriate dose for a treatment combo: hyper-CVAD with dasatinib and venetoclax, in children who have relapsed or refractory leukemia.

What are the potential side effects?

Possible side effects may include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk, bleeding complications, liver dysfunction, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

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

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My hepatitis B virus load is undetectable with treatment.

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I have B-ALL and have been treated with CD19-targeted therapy before.

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I am a young patient with a specific type of leukemia that has not responded to treatment.

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I am over 16 and can care for myself, or if under 16, I can do most activities.

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I am between 2 and 21 years old.

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I have brain involvement from my cancer but no symptoms.

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I had hepatitis C but have been successfully treated and cured.

Exclusion Criteria

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

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I have severe liver disease or cirrhosis, or I am currently abusing alcohol.

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I do not have uncontrolled brain-related health issues.

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I have a heart condition that needs medication.

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I am not pregnant or breastfeeding.

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I do not have an active or uncontrolled HIV/AIDS infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

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 1bExperimental Treatment2 Interventions

Participants enrolled in Phase 1b, will receive venetoclax at the recommended dose that was found in Phase 1. The study doctor will discuss with you the doses the participants will receive as part of hyper-CVAD based on standard of care.

Group II: Phase 1aExperimental Treatment2 Interventions

Participants enrolled in Phase 1a, the dose of venetoclax the participant receive will depend on when the participant joins this study. The first group of participants will receive the lowest dose level of venetoclax. Each new group will receive a higher dose of venetoclax than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of venetoclax is found. The study doctor will discuss with you the doses the participants will receive as part of hyper-CVAD based on standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Hyper-CVAD

2010

Completed Early Phase 1

~10