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

NCT03412409 | Recruiting Phase 2

• 1 other identifier: Haplo-RIC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Leukemia; Myelodysplastic Syndromes

Keywords

RIC regimen; comorbidity; elderly; haploidentical; transplant-related mortality

Outcome Measures

Primary Outcomes (1)

• Transplant-related mortality

  Death without disease progression or relapse

  Participants will be followed for an expected average of 1 years

Study Arms (1)

RIC regimen

EXPERIMENTAL

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

Interventions

Cytarabine DRUG

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).

Also known as: Busulfan, Cyclophosphamide, Fludarabine, Semustine, Antithymocyte globulin

RIC regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University, Institute of Hematolgoy

Beijing, China

RECRUITING

Related Publications (3)

• Sun W, Sun Y, Mo X, Ma R, He Y, Zhang Y, Chen Y, Wang F, Chen H, Chen Y, Yan C, Han W, Xu L, Wang Y, Zhang X, Liu K, Huang X. A novel and safe protocol for patients with severe comorbidity who undergo haploidentical hematopoietic stem cell transplantation: A single-center prospective study. J Transl Int Med. 2025 May 8;13(2):128-137. doi: 10.1515/jtim-2025-0018. eCollection 2025 Apr.

  PMID: 40443407 DERIVED

• Yu WJ, Sun YQ, Zhang XH, Xu LP, Mo XD, Lv M, Huang XJ, Wang Y. A novel reduced toxicity conditioning regimen for older myelodysplastic neoplasms patients undergoing haploidentical stem cell transplantation: a prospective cohort study. Am J Cancer Res. 2025 Jan 15;15(1):182-194. doi: 10.62347/OFXJ3130. eCollection 2025.

  PMID: 39949947 DERIVED

• Sun YQ, Han TT, Wang Y, Yan CH, Wang FR, Wang ZD, Kong J, Chen YH, Chen H, Han W, Chen Y, Zhang YY, Zhang XH, Xu LP, Liu KY, Huang XJ. Haploidentical Stem Cell Transplantation With a Novel Conditioning Regimen in Older Patients: A Prospective Single-Arm Phase 2 Study. Front Oncol. 2021 Feb 26;11:639502. doi: 10.3389/fonc.2021.639502. eCollection 2021.

  PMID: 33718234 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Cytarabine; Busulfan; Cyclophosphamide; fludarabine; Semustine; Antilymphocyte Serum

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Lomustine; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Xiao-Jun Huang

  Institute of Hematology, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Mo, MD

CONTACT

8610-8832-6001; mxd453@163.com

Xiao-Dong Mo

CONTACT

8610-8832-4577; mxd453@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: February 1, 2018
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)