Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

Myelodysplastic Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674985
• Other study ID #: MST/MDS-307PLAH-ASH
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2012
• Last updated: July 12, 2016
• Start date: September 2009
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Biological:
• Microtransplantation
Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences	The Second Artillery General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival		three years	Yes
Primary	complete remission		six months	Yes
Secondary	disease-free survival		three years	Yes