RecruitingPhase 1NCT05292664

Venetoclax Basket Trial for High Risk Hematologic Malignancies

A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies


Sponsor

Andrew E. Place, MD

Enrollment

30 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. * Venetoclax * Azacitidine * Cytarabine * Methotrexate * Hydrocortisone * Leucovorin * Dexamethasone * Vincristine * Doxorubicin * Dexrazoxane * Calaspargase pegol * Hydrocortisone


Eligibility

Min Age: 1 YearMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests venetoclax (a targeted cancer drug) in children, teenagers, and young adults with high-risk blood cancers including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) that is newly diagnosed or has come back after prior treatment. **You may be eligible if...** - You have been diagnosed with MDS or AML (including therapy-related forms) - You are 40 years old or younger (some sub-groups require age under 18) - Your cancer has high-risk features, has not responded to treatment, or has relapsed - Your organ function (heart, kidney, liver) is adequate for treatment **You may NOT be eligible if...** - You do not have a confirmed diagnosis of MDS or AML - You are over the age limit for your specific disease subgroup - You have another cancer requiring active treatment - You have serious infection or organ dysfunction 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

Tablet taken orally

DRUGAzacitidine

Taken intravenously

DRUGCytarabine

Lumbar Puncture

DRUGMethotrexate

Lumbar Puncture

DRUGHydrocortisone

Lumbar Puncture

DRUGLeucovorin

Taken Orally or intravenously

DRUGDexamethasone

Taken Orally or intravenously

DRUGVincristine

Taken intravenously

DRUGDoxorubicin

Taken intravenously

DRUGDexrazoxane

Taken intravenously

DRUGCalaspargase Pegol

Taken intravenously

DRUGErwinia asparaginase

Given as intramuscular injection


Locations(5)

University of California San Francisco-Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta at Arthur M. Blank Hospital

Atlanta, Georgia, United States

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05292664


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