Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT
14. september 2026 oppdatert av: Xiao-Jun Huang, Peking University People's Hospital
Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation
This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation.
After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged <55 years) followed by unified post-transplant immunosuppression and supportive care.
The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yu Wang
- Telefonnummer: 8610-8832-6005
- E-post: ywyw3172@sina.com
Studiesteder
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-
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Beijing, Kina
- Rekruttering
- Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University
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Ta kontakt med:
- Xiaojun Huang
- Telefonnummer: 8610-8832-6005
- E-post: huangxiaojun@bjmu.edu.cn
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation
Exclusion Criteria:
- Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Age-Stratified Conditioning Regimen
MDS patients without identical sibling donor or unrelated donor would receive haplo-HSCT.
Participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged <55 years) followed by unified post-transplant immunosuppression and supportive care.
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RTC preconditioning regimen consisted of cytarabine (2g/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/m2/day, days -6 to -2), semustine (250 mg/m2, day-3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Bu/Cy preconditioning regimen consisted of tandard institutional myeloablative busulfan + cyclophosphamide + rabbit ATG regimen per department routine dosing guidelines.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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transplant-related mortality (TRM)
Tidsramme: Participants will be followed for an expected average of 1 years
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Death without disease progression or relapse
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Participants will be followed for an expected average of 1 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hematopoietic engraftment
Tidsramme: Day 30 and Day 90 post-transplantation
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Neutrophil engraftment is defined as the first day of sustained absolute neutrophil count (ANC) ≥0.5×10⁹/L for 3 consecutive days; platelet engraftment is defined as the first day of sustained platelet count (PLT) ≥20×10⁹/L without transfusion support for 7 consecutive days.
Cumulative incidence of neutrophil engraftment at Day 30 and platelet engraftment at Day 90 will be calculated.
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Day 30 and Day 90 post-transplantation
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Cumulative incidence of graft-versus-host disease (GVHD)
Tidsramme: Day 100 and 3 years after transplantation
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Cumulative incidence of Grade II-IV and Grade III-IV acute GVHD at Day 100, as well as chronic GVHD and moderate-severe chronic GVHD within 3 years after transplantation, graded per Seattle criteria.
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Day 100 and 3 years after transplantation
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Cumulative incidence of CMV and EBV reactivation
Tidsramme: 1 year after transplantation
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Defined as any detectable CMV or EBV viral load elevation requiring clinical intervention within 1 year after transplantation.
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1 year after transplantation
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Cumulative incidence of hematologic relapse
Tidsramme: 1 year after transplantation
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Defined as bone marrow blast recurrence or extramedullary disease relapse within 1 year after transplantation.
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1 year after transplantation
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Disease-free survival (DFS)
Tidsramme: 1 year after transplantation
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Defined as the time from transplantation until hematologic relapse or death from any cause.
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1 year after transplantation
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Overall survival（OS）
Tidsramme: 1 year after transplantation
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Defined as the time from treatment until death from any cause or the last follow-up.
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1 year after transplantation
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Conditioning-related organ toxicities
Tidsramme: From conditioning start to Day 30 post-transplantation
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Incidence of grade 1-4 cardiac, renal, hepatic, gastrointestinal and oral mucosal toxicities from conditioning initiation to Day +30 post-transplantation, with separate analysis of Grade 3-4 severe organ injury, hepatic veno-occlusive disease (VOD), and conditioning-related death, graded per WHO organ toxicity scale.
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From conditioning start to Day 30 post-transplantation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Xiao-Jun Huang, Peking University Institute of Hematology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
30. juni 2028
Datoer for studieregistrering
Først innsendt
24. juni 2026
Først innsendt som oppfylte QC-kriteriene
24. juni 2026
Først lagt ut (Faktiske)
30. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RTC Haplo-MDS
Plan for individuelle deltakerdata (IPD)
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