search
Back to results

Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Microtransplantation
Sponsored by
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Decitabine, microtransplantation, myelodysplastic syndromes, chemotherapy

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Affiliated Hospital of Academy of Military Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine and cytarabine

Arm 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

Outcomes

Primary Outcome Measures

complete remission

Secondary Outcome Measures

disease-free survival

Full Information

First Posted
August 25, 2012
Last Updated
July 12, 2016
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators
The Second Artillery General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01674985
Brief Title
Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators
The Second Artillery General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Decitabine, microtransplantation, myelodysplastic syndromes, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decitabine and cytarabine
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Microtransplantation
Intervention Description
Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
Primary Outcome Measure Information:
Title
complete remission
Time Frame
six months
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
three years
Other Pre-specified Outcome Measures:
Title
overall survival
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng Hui Ai, M.D
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20966170
Citation
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.
Results Reference
background

Learn more about this trial

Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

We'll reach out to this number within 24 hrs