Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674985

Enrollment

Registered

2012-08-29

Start date

2009-09-30

Completion date

2015-12-31

Last updated

2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

Decitabine, microtransplantation, myelodysplastic syndromes, chemotherapy

Brief summary

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.

Interventions

BIOLOGICALMicrotransplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
complete remission	six months

Secondary

Measure	Time frame
disease-free survival	three years

Other

Measure	Time frame
overall survival	three years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026