A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute
myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not
responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:
Patients will receive 6 treatment cycles unless disease progression, transformation, or
unacceptable toxicity occurs, or the patient refuses to continue participating in the study.
Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients
demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of
Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until
progression.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborator:
Advancell - Advanced In Vitro Cell Technologies, S.A.