RecruitingPhase 1NCT05317403

Venetoclax to Augment Epigenetic Modification and Chemotherapy

A Phase I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia


Sponsor

Medical College of Wisconsin

Enrollment

40 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.


Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests venetoclax — a drug that blocks proteins that help cancer cells survive — combined with epigenetic (gene-regulating) drugs and chemotherapy for children and young adults with relapsed or difficult-to-treat acute myeloid leukemia (AML), a serious blood cancer. **You may be eligible if...** - You have AML that has relapsed (come back) at least once, OR failed to go into remission after multiple attempts at induction chemotherapy - Patients with treatment-related AML (tAML), including newly diagnosed tAML, may also be eligible - You have measurable leukemia in the bone marrow - You may have cancer in the brain or other sites outside the bone marrow **You may NOT be eligible if...** - You have had prior cranial (brain) radiation during this treatment protocol - You have severe organ dysfunction that makes chemotherapy unsafe - You have had certain prior treatments that conflict with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Dose Level 0: Day 1 60 mg/m2 PO x1, Days 2-14 120 mg/m2/dose PO once daily (Max: 200 mg/day) Dose level 1: Day 1 120 mg/m2 PO x1, Days 2-14 240 mg/m2/dose PO once daily (Max: 400 mg/day) Dose level 2: Day 1 180 mg/m2 PO x1, Days 2-14 360 mg/m2/dose PO once daily (Max: 600 mg/day)

DRUGAzacitadine

75 mg/m2/dose IV once daily over 15 minutes

DRUGVorinostat

1 year to 17.99 years old: 180 mg/m2/dose PO once daily ≥18 years old 200 mg PO BID. Doses should be separated by 12 hr (±4 hr)

DRUGCytarabine

2000 mg/m2/dose IV once daily over 3 hours IT Cytarabine: 1. \- 1.99 years old: 30 mg 2. \- 2.99 years old: 50 mg * 3 years old: 70 mg

DRUGFludarabine

30 mg/m2/dose IV once daily over 30 minutes

DRUGFilgrastim

5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily


Locations(1)

Children's Wisconsin

Milwaukee, Wisconsin, United States

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NCT05317403


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