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RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT

Primary Purpose

Myelodysplastic Syndromes

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cytarabine
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring RIC regimen; MDS; haplo-HSCT; survival

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

  • Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure

Sites / Locations

  • Peking University Institute of Hematology,BeijingRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RIC regimen

Arm Description

Low- and intermediate MDS patients without identical sibling donor or unrelated donor would receive RIC haplo-HSCT. RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).

Outcomes

Primary Outcome Measures

Transplant-related mortality
Death without disease progression or relapse

Secondary Outcome Measures

Full Information

First Posted
January 21, 2018
Last Updated
April 19, 2022
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03412266
Brief Title
RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT
Official Title
Reduced Intensity Conditioning Regimen for Low- and Intermediate-risk Myelodysplastic Syndrome Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in low- and intermediate-risk myelodysplastic syndrome (MDS) patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for MDS patients who did not have identical sibling donor (ISD) or unrelated donor (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes for transplant failure in MDS patients, and the risk of TRM for haplo-HSCT recipients was higher than that of ISD recipients. RIC regimen can decrease the risk of TRM for haplo-HSCT recipients; however, the risk for relapse may increase in these patients. Thus, RIC regimen may be more appropriate for low- and intermediate-risk MDS patients receiving haplo-HSCT. The study hypothesis: Using RIC haplo-HSCT regimen in patients with low- and risk MDS can reduce TRM and improve survival.
Detailed Description
RIC regimen was given for low and intermediate MDS patients who would receive haplo-HSCT. The primary end point was transplant-related mortality. The secondary end points were overall survival, disease-free survival, relapse, , graft-versus-host disease (GVHD), and infections. Following time is 1 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
RIC regimen; MDS; haplo-HSCT; survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC regimen
Arm Type
Other
Arm Description
Low- and intermediate MDS patients without identical sibling donor or unrelated donor would receive RIC haplo-HSCT. RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
busulfan, Cyclophosphamide, Fludarabine, Semustine, antithymocyte globulin
Intervention Description
RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Primary Outcome Measure Information:
Title
Transplant-related mortality
Description
Death without disease progression or relapse
Time Frame
Participants will be followed for an expected average of 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation Exclusion Criteria: Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Dong Mo
Phone
8610-8832-6001
Email
mxd453@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Dong Mo
Phone
8610-8832-4577
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Huang
Organizational Affiliation
Peking University Institute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology,Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Dong Mo
Email
mxd453@163.com
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Huang, MD

12. IPD Sharing Statement

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RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT

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