Venetoclax Basket Trial

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

What's the purpose of the trial?

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
Trial status

Accepting patients

Phase
Phase 1
Enrollment
92
Last Updated
9 months ago
Am I Eligible

Participating Centers

There are 2 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Calaspargase Pegol is a chemotherapy medication that is approved to treat patients with acute lymphoblastic leukemia (ALL).
  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Dexrazoxane Hydrochloride is a cardioprotective agent that is given alongside some chemotherapies to help protect from side effects.
  • Doxorubicin is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Hydrocortisone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Leucovorin is a form of folic acid that is typically given after certain types of chemotherapy to protect against side effects.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 
  • Vincristine is an antineoplastic agent used to treat different kinds of cancer. 

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