Inotuzumab + Venetoclax + Dexamethasone for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJeremy Rubinstein, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are: Is the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients? What medical problems do patients taking IoVeX experience? Participants will: Receive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days. Have checkups and tests at the beginning of the study and throughout the course of each cycle.

Eligibility Criteria

This trial is for pediatric and adult patients with relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL). Participants should have experienced a return of leukemia after initial treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

I am between 1 and 39 years old.

I took Venetoclax but stopped it at least 30 days ago.

My B-ALL has returned with more than 5% cancer cells in my bone marrow.

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Exclusion Criteria

I have had SOS before, regardless of how severe it was.

I have recovered from side effects of previous cancer treatments, except for hair loss.

I have CNS3 disease at the time of joining the study.

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Inotuzumab Ozogamicin (Monoclonal Antibodies)
Venetoclax (Anti-tumor antibiotic)

Trial OverviewThe study tests the safety and tolerance of a drug combo called IoVeX (Inotuzumab Ozogamicin, Venetoclax, Dexamethasone) in treating relapsed B-ALL. Patients receive IoVeX over one 28-day cycle with an option to continue if well-tolerated. They'll undergo regular checkups and tests.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: IoVeXExperimental Treatment1 Intervention