Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelodysplastic Syndromes

Treatments: Biological: Microtransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01674985

MST/MDS-307PLAH-ASH

Details and patient eligibility

About

The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.

Enrollment: 43 patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
• International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
• bone marrow blasts > 11% or <= 10% and poor cytogenetics;
• lack of an HLA-identical donor;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• adequate cardiac and hepatorenal functions.

Exclusion criteria

• have an HLA-identical donor

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Decitabine and cytarabine

Experimental group

Description:

induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days

Treatment:

Biological: Microtransplantation