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

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ClinicalTrials.gov Identifier: NCT03412266
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Xiao-Jun Huang, Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Cytarabine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduced Intensity Conditioning Regimen for Low- and Intermediate-risk Myelodysplastic Syndrome Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cytarabine

Arms and Interventions
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Arm Intervention/treatment
RIC regimen

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).

 Drug: Cytarabine
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).
Other Names:
  • busulfan
  • Cyclophosphamide
  • Fludarabine
  • Semustine
  • antithymocyte globulin


Outcome Measures
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Primary Outcome Measures :
  1. Transplant-related mortality [ Time Frame: Participants will be followed for an expected average of 1 years ]
    Death without disease progression or relapse


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412266


Contacts
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Contact: Xiao-Dong Mo 8610-8832-6001 mxd453@163.com
Contact: Xiao-Dong Mo 8610-8832-4577

Locations
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China, Beijing
Peking University Institute of Hematology,Beijing Recruiting
Beijing, Beijing, China, 100044
Contact: Xiao-Dong Mo       mxd453@163.com   
Principal Investigator: Xiao-Jun Huang, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiao-Jun Huang Peking University Institute of Hematology
More Information
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Responsible Party: Xiao-Jun Huang, Director, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03412266    
Other Study ID Numbers: RIC Haplo-MDS
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao-Jun Huang, Peking University People's Hospital:
RIC regimen; MDS; haplo-HSCT; survival
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Cytarabine
Cyclophosphamide
Busulfan
Semustine
Fludarabine
 Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents