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

Sponsor
Technische Universität Dresden
Study ID
NCT04330820
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Refractory AML
  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax Oral Tablet — DRUG
    This study will investigate the combination of a fixed maximum venetoclax dose with increasing cytarabine doses plus mitoxantrone in a fixed dose in phase I. In Phase II cytarabine will be given at MDT or RP2D that assessed in phase I. The venetoclax dose of 400 mg will be reached by a ramp up over 3 days. Parallel chemotherapy with cytarabine and mitoxantrone will start on day 3.

Study Details

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.

Key Dates

Start date
Apr 6, 2020
Status verified
Feb 2024
Primary completion
Oct 11, 2023
Completion
Aug 31, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax+Cytarabin+ Mitoxantron
    The treatment plan combines a fixed dose of venetoclax and mitoxantrone with increasing doses of cytarabine (V-MAC).

Primary Outcome Measure

Maximum tolerated dose (= recommended phase II dose) of cytarabine in combination with venetoclax plus mitoxantrone [ Time Frame: appr. 9 months ]

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