Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve AML

  • STATUS
    Not Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    64
  • sponsor
    Dana-Farber Cancer Institute
Updated on 28 April 2022
hydroxyurea
cytarabine
tretinoin
hematologic disorder
gilbert's syndrome
daunorubicin
secondary acute myeloid leukemia
consolidation chemotherapies
blast cells
venetoclax

Summary

This research study is studying the combination of venetoclax and chemotherapy as a possible treatment for acute myelogenous leukemia (AML).

The drugs involved in this study are:

  • Venetoclax
  • Daunorubicin
  • Cytarabine

Description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved venetoclax for this specific disease but it has been approved for other uses.

In this research study, the investigators are combining the use of venetoclax (the investigational drug being studied) with chemotherapy drugs daunorubicin and cytarabine. The investigators are looking to determine the highest dose of venetoclax that can be given safely in combination with these chemotherapy drugs.

Depending on when the participant join the study, the participant may participate in part 1 (induction with venetoclax escalation), part 2 (consolidation with venetoclax escalation), or part 3 (an expansion cohort utilizing the maximum tolerated doses identified in parts 1 and 2). The study doctor will tell the participant which part of the study they will join.

Details
Condition Acute Myeloid Leukemia
Treatment cytarabine, Daunorubicin, venetoclax
Clinical Study IdentifierNCT03709758
SponsorDana-Farber Cancer Institute
Last Modified on28 April 2022

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