MDS Clinical Trial
Official title:
A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response
Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.
All eligible patients will be treated with SGI-110 for 9 cycles of 28 days.
Patients who meet eligibility criteria will be administered subcutaneous SGI-110 at 60mg/m²/d
one time daily for 5 days. Each cycle will last 28 days with SGI-110 starting on day 1 of
each cycle. Patients will receive at least 9 cycles unless overt progression is documented.
(Overt progression will be defined by the presence of more than 30% marrow blasts and
doubling of marrow blast percentage from onset of SGI-110). Dose reduction to 45 and even 30
mg/m²/d will be made in case of toxicity.
Patients with Complete Remission (CR), Partial Remission (PR), marrow CR, Hematological
Improvement (HI) or stable disease (SD) after 6 Cycles of therapy (IWG 2006 criteria) may
receive 3 additional cycles. Response will be re-evaluated after 9 cycles. Patients with no
response (NR) to treatment after 9 cycles will be withdrawn from the protocol. Patients with
progression at any time will be withdrawn from the protocol after the last treatment Cycle.
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