Overview

Study of Sensitization of Non-M3 AML Blasts to ATRA by Epigenetic Treatment With Tranylcypromine (TCP)

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The objective of the phase I part of the trial is the determination of the maximum tolerated dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or who failed azanucleoside treatment. The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for further investigations of TCP
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Michael Luebbert
Ulrike Kohlweyer
Collaborator:
University Hospital Freiburg
Treatments:
Cytarabine
Tranylcypromine
Tretinoin