Myelodysplastic syndrome(MDS)
Conditions
Interventions
Azacitidine 20 mg/m2/day, 5days
Azacitidine 30 mg/m2/day, 5days
Azacitidine 40 mg/m2/day, 5days
Azacitidine 50 mg/m2/day, 5days
Sponsors
Kanto Study Group for Cell Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 65 years-old (2) After receiving allogeneic hematopoietic stem cell transplant for high-risk MDS (IPSS int-2 or high) in FAB classification. (3) Engraftment with sufficient hematopoiesis (4) Remission after allogeneic stem cell transplant (5) Between days 40 and 180 post-transplantation (6) ECOG performance status score 0 to 2 (7) Enough organ function (8) With written informed consent
Exclusion criteria
Exclusion criteria: (1) Allergic to azacitidine (2) With active uncontrollable infectious diseases (3) With severe mental disorder (4) With severe acute GHVD Grade III to IV (5) Requiring 2nd line therapy for acute GVHD due to unsuccessful 1st line therapy (6) Uncontrollable chronic GVHD (7) Under treatment of anti-CMV drug (8) Those evaluated ineligible by attending doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate of feasible initial dose Completion rate of total 4 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence of dose limiting toxicity (2) Incidence of adverse events (3) Time to progression | — |
Countries
Japan
Contacts
Public ContactYuho Najima
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital Hematology division
Outcome results
None listed