RIC Regimen for Elderly or High Comorbidity Burden Patients Receiving Haplo-HSCT

March 24, 2024 updated by: Xiao-Jun Huang, Peking University People's Hospital

Reduced Intensity Conditioning Regimen for Elderly or High Comorbidity Burden Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation

This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in elderly or high comorbidity burden patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for 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, and the risk of TRM for old patients or those with high comorbidity burden was higher. RIC regimen may decrease the risk of TRM for haplo-HSCT recipients. The study hypothesis: Using RIC haplo-HSCT regimen in elderly patients or those with high comorbidity burden can reduce TRM and improve survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RIC regimen was given for elderly patients or those with high comorbidity burden who would receive haplo-HSCT. The elderly patients were defined as older than 55 years. The burden of comorbidities in HSCT recipients was assessed based on the hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and patients with score ≥3 were assigned as high burden. The primary end point was transplant-related mortality, and the secondary endpoints included overall survival, disease-free survival, relapse, engraftment, graft-versus-host disease (GVHD), and infections. Following time is 1 years.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiao-Dong Mo, MD
  • Phone Number: 8610-8832-6001
  • Email: mxd453@163.com

Study Contact Backup

  • Name: Xiao-Dong Mo
  • Phone Number: 8610-8832-4577
  • Email: mxd453@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University, Institute of Hematolgoy
        • Contact:
          • Xiao-Dong Mo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients older than 55 years or those with HCT-CI scores of ≥3, without ISD nor URD, receiving haplo-HSCT

Exclusion Criteria:

  • patients having identical sibling or unrelated donors; patients with active infection; patients having organ failure; patients with poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIC regimen

Old patients or those have high comorbidity burden 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:
  • Cyclophosphamide
  • Fludarabine
  • Busulfan
  • Semustine
  • Antithymocyte globulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant-related mortality
Time Frame: Participants will be followed for an expected average of 1 years
Death without disease progression or relapse
Participants will be followed for an expected average of 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Xiao-Jun Huang, Institute of Hematology, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 21, 2018

First Submitted That Met QC Criteria

January 21, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haplo-RIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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