NCT02197676

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 Patients with no response (NR) to treatment after 9 cycles will be withdrawn from the protocol. Patients with progression at any time will be withdrawn from the protocol after the last treatment Cycle.

Conditions

• MDS

Interventions

Type	Name	Description
DRUG	SGI-110 administration	SGI-110 will be administered SC at 60 mg/m²/day x5 consecutive days for each cycle. Cycle duration is 28 days. Patients with Complete Remission (CR), Partial Remission (PR), marrow CR or Hematological Improvement (HI) after 6 Cycles of therapy (IWG 2006 criteria) may continue treatment until progression. A dose reduction to 45 and even 30 mg/m²/day will be made in case of haematological toxicity. Patients with no response (NR) to treatment will be withdrawn from the protocol after the last treatment Cycle.

Timeline

• Start date: 2014-08-04
• Primary completion: 2016-02-06
• Completion: 2018-04-23
• First posted: 2014-07-23
• Last updated: 2018-12-06

Locations

27 sites across 1 country: France