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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-related mortality | Death without disease progression or relapse | Participants will be followed for an expected average of 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Dong Mo, MD | Contact | 8610-8832-6001 | mxd453@163.com | |
| Xiao-Dong Mo | Contact | 8610-8832-4577 | mxd453@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jun Huang | Institute of Hematology, Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University, Institute of Hematolgoy | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40443407 | Derived | 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. | |
| 39949947 |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D012673 | Semustine |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| 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. |
| 33718234 | 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. |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008130 | Lomustine |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |