Trial for Relapsed or Refractory AML Patients Combining Cytarabine and Mitoxantrone With Venetoclax (RELAX)

  • STATUS
    Not Recruiting
  • End date
    Apr 15, 2025
  • participants needed
    60
  • sponsor
    Technische Universität Dresden
Updated on 15 September 2023
cytarabine
cell transplantation
induction chemotherapy
mitoxantrone
refractory acute myeloid leukemia (aml)
acute promyelocytic leukemia

Summary

This is an open-label Phase I dose-escalation study of oral venetoclax in combination with increasing cytarabine doses plus mitoxantrone to define the safety profile and MTD of cytarabine in subjects with a histologically or cytologically confirmed acute myeloid leukemia who are refractory or suffered a relapse. This study will be conducted at multiple centers in Germany.

Description

  • To determine safety, tolerability, maximum tolerated dose, and recommended phase II dose of venetoclax in combination with increasing cytarabine doses plus fixed dose mitoxantrone in subjects with a relapsed or refractory AML considered fit for intensive salvage therapy.
    • To assess the preliminary efficacy of venetoclax in combination with increasing cytarabine doses plus fixed dose mitoxantrone in subjects with a relapsed or refractory AML considered fit for intensive salvage therapy.

Details
Condition Relapsed Adult AML
Treatment Venetoclax Oral Tablet
Clinical Study IdentifierNCT04330820
SponsorTechnische Universität Dresden
Last Modified on15 September 2023

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