Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I/II Study of Sensitization of Non-M3 Acute Myeloid Leukemia (AML) Blasts to All-trans Retinoic Acid (ATRA) by Epigenetic Treatment With Tranylcypromine (TCP), an Inhibitor of the Histone Lysine Demethylase 1 (LSD1)
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
Study treatment: TCP + ATRA + AraC Four dose levels of TCP (20 mg, 40 mg, 60 mg, 80 mg on
days 1-28) will be examined in combination with fixed dose ATRA (45 mg/m2 on days 10-28) and
fixed-dose AraC (40 mg on days 1-10) in the first cycle.
In further cycles patients will be treated in the same manner, except for ATRA which will be
administered continuously with a nine-day interruption at the beginning of every fourth
cycle.
Follow-up per patient: Until twelve months after registration of the last patient.
Duration of intervention per patient: Until relapse/progression, unacceptable toxicity or
until twelve months after registration of the last patient, whatever occurs first
;
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