Clinical trial

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

Name

Haplo-RIC

Description

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.

Trial arms

Trial start

2018-02-01

Estimated PCD

2025-09-01

Trial end

2025-09-01

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

RIC regimen

Other names:

Busulfan, Cyclophosphamide, Fludarabine, Semustine, Antithymocyte globulin

Size

Primary endpoint

Transplant-related mortality

Participants will be followed for an expected average of 1 years

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-03-26

1 organization

1 product

2 indications

Organization

Peking University People's Hospital

Product

Cytarabine

Indication

Acute Lymphoblastic Leukemia

Indication

Myelodysplastic Syndromes