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Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT

1. juli 2026 opdateret af: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial of Anti-CD25 Monoclonal Antibody Versus Methotrexate for the Prevention of Acute Graft-Versus-Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation

Acute graft-versus-host disease remains a major complication after haploidentical hematopoietic stem cell transplantation. Methotrexate is commonly used as part of graft-versus-host disease prophylaxis, but it may be associated with delayed hematopoietic recovery and transplant-related toxicities, including oral mucositis.

This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase III clinical trial designed to evaluate an anti-CD25 monoclonal antibody regimen compared with methotrexate for the prevention of acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation. Eligible patients with hematologic malignancies scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation will be randomly assigned in a 1:1 ratio to receive either methotrexate-based prophylaxis or anti-CD25 monoclonal antibody-based prophylaxis, in combination with standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.

The primary objective is to compare 12-month graft-versus-host disease-free, relapse-free survival between the two groups. Secondary objectives include comparison of acute graft-versus-host disease, chronic graft-versus-host disease, oral mucositis, hematopoietic recovery, cytomegalovirus and Epstein-Barr virus reactivation, infection, relapse, non-relapse mortality, overall survival, and leukemia-free survival.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

186

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria：

  1. Patients with confirmed hematologic malignancies who are scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation.
  2. Age 18 to 75 years.
  3. Willing to provide written informed consent and accept random assignment.
  4. Willing and able to comply with the study procedures throughout the study period.

Exclusion Criteria:

  1. Patients scheduled to undergo fully matched donor transplantation, unrelated donor transplantation, or umbilical cord blood transplantation.
  2. Patients receiving grafts from maternal donors or collateral relative donors.
  3. Patients with strongly positive donor-specific antibodies.
  4. Patients whose transplantation regimen includes post-transplant cyclophosphamide for graft-versus-host disease prophylaxis.
  5. Patients undergoing a second transplantation.
  6. Patients who refuse to provide written informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Methotrexate Group
Participants in this arm will receive methotrexate-based graft-versus-host disease prophylaxis after haploidentical hematopoietic stem cell transplantation. Methotrexate will be administered intravenously at 15 mg/m² on Day +1 and 10 mg/m² on Days +3, +6, and +11 after transplantation. Participants will also receive standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.
Medicin: Methotrexate
Methotrexate will be administered intravenously at 15 mg/m² on Day +1 and 10 mg/m² on Days +3, +6, and +11 after haploidentical hematopoietic stem cell transplantation for graft-versus-host disease prophylaxis.
Eksperimentel: Anti-CD25 Monoclonal Antibody Group
Participants in this arm will receive anti-CD25 monoclonal antibody-based graft-versus-host disease prophylaxis after haploidentical hematopoietic stem cell transplantation. Anti-CD25 monoclonal antibody will be administered intravenously at 1 mg/kg on Day 0 and Day +4 after transplantation. On Day 0, the drug will be administered 2 hours before stem cell infusion. Participants will also receive standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.
Biologisk: Anti-CD25 Monoclonal Antibody
Anti-CD25 monoclonal antibody, also described as daclizumab in the protocol, will be administered intravenously at 1 mg/kg on Day 0 and Day +4 after haploidentical hematopoietic stem cell transplantation for graft-versus-host disease prophylaxis. The Day 0 dose will be administered 2 hours before stem cell infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
12-month graft-versus-host disease-free, relapse-free survival
Tidsramme: 12 months after transplantation
Graft-versus-host disease-free, relapse-free survival is defined as survival without grade III-IV acute graft-versus-host disease, moderate or severe chronic graft-versus-host disease, disease relapse, or death from any cause, whichever occurs first.
12 months after transplantation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of acute graft-versus-host disease
Tidsramme: Up to 100 days after transplantation
Proportion of participants who develop acute graft-versus-host disease after transplantation. Acute graft-versus-host disease will be assessed according to international criteria and MAGIC grading.
Up to 100 days after transplantation
Incidence of grade II-IV acute graft-versus-host disease
Tidsramme: Up to 100 days after transplantation
Proportion of participants who develop grade II-IV acute graft-versus-host disease after transplantation.
Up to 100 days after transplantation
Incidence of grade III-IV acute graft-versus-host disease
Tidsramme: Up to 100 days after transplantation
transplantation Proportion of participants who develop grade III-IV acute graft-versus-host disease after transplantation.
Up to 100 days after transplantation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Efterforskere

  • Ledende efterforsker: Linghui Xia, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UHCT260630

Plan for individuelle deltagerdata (IPD)

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INGEN

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