Venetoclax Basket Trial for High Risk Hematologic Malignancies

Phase 1 Recruiting 30 enrolled Andrew E. Place, MD AbbVie · collab Boston Children's Hospital · collab Children's Cancer Research Fund · collab Gateway for Cancer Research · collab Servier · collab University of Colorado, Denver · collab

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2023-03-29
Primary completion: 2028-07-02
Completion: 2030-07-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	—	Oral
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	—	Intramuscular
Background	Azacitidine	Other / unclassified	—	Intravenous
Background	Calaspargase Pegol	Protein / enzyme biologic	—	Intravenous
Background	Cytarabine	Small molecule	—	Intrathecal
Background	Dexamethasone	Small molecule	—	Oral
Background	Dexrazoxane	Small molecule	—	Intravenous
Background	Doxorubicin	Other / unclassified	—	Intravenous
Background	Hydrocortisone	Other / unclassified	—	Intrathecal
Background	Leucovorin	Small molecule	—	Oral
Background	Methotrexate	Small molecule	—	Intrathecal
Background	Vincristine	Small molecule	—	Intravenous

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Summary

Timeline

Drugs

Indications