Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes

Interventions

MicrotransplantationBIOLOGICAL

Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)

Eligibility

Sex: ALLMin age: 10 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

complete remission

Time frame: six months

Secondary Outcomes

disease-free survival

Time frame: three years

Data from ClinicalTrials.gov

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