Clinical trial · Interventional
RIC Regimen for Elderly or High Comorbidity Burden Patients Receiving Haplo-HSCT
Reduced Intensity Conditioning Regimen for Elderly or High Comorbidity Burden Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RIC regimen
- description
- 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).
- interventionNames
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Transplant-related mortality
- timeFrame
- Participants will be followed for an expected average of 1 years
- description
- Death without disease progression or relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDSun 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
- DERIVEDYu 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
- DERIVEDSun 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