Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT
13. marts 2022 opdateret af: Qifa Liu, Nanfang Hospital of Southern Medical University
A Comparative Study of Haploidentical Transplantation Supported by Third-party Cord Blood and Haploidentical Transplantation in Hematological Malignancies
The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse.
In recent years, with the development of transplantation technology, alternative donors such as HID and UCB have been widely used.
But, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (HLA)-matched donors.
Some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft.
UCB transplant (UCBT) supported by third-party HID or HID transplants supported by third-party UCB has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (GVHD), making survival improvement.
However, most of these results came from single-arm studies.
The comparative studies between haplo-PBSC+Cord and haplo-PBSC+BM are scarce in the setting of HID transplantation.
In a retrospective study, the investigators found haplo-PBSC+Cord transplantation has superior DFS than haplo-PBSC+BM in hematological malignancies.
To further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
314
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiangzong Zeng
- Telefonnummer: +86-020-62787883
- E-mail: gdzxz1990@163.com
Undersøgelse Kontakt Backup
- Navn: Qifa Liu
- Telefonnummer: +86-020-62787883
- E-mail: liuqifa628@163.com
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekruttering
- Department of Hematology,Nanfang Hospital, Southern Medical University
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Kontakt:
- Qifa Liu
- Telefonnummer: +86-020-62787883
- E-mail: liuqifa628@163.com
-
-
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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with hematologic malignancies undergoing first HID allo-HSCT
- Age 18 to 65 years old with ECOG performance status 0-2
- Received myeloablative conditioning regimens
- Sign informed consent form, have the ability to comply with study and follow-up procedures
Exclusion Criteria:
- Received PBSCs as only grafts
- Acute leukemia transformed from a myeloproliferative tumor
- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure ( PaO2 ≤60mmHg)
- Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
- Renal dysfunction (creatinine clearance rate < 30 mL/min)
- ECOG performance status 3, 4 or 5
- With any conditions not suitable for the trial (investigators' decision)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Haplo-PBSC+Cord group
The third party UCB will be infused the day after infusion of PBSCs from HID.
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PBSCs harvest is performed from day 5 of G-CSF to obtain at least 7.0×10^8 total nucleated cells/kg recipient ideal body weight.
The criteria for cord selection included the following: (1) ≥3 of 6 HLA loci , (2) blood type matches, (3) contained a minimum cell count of 0.3×10^8 nucleated cells/kg and 0.15×10^6 CD34-positive cells/kg before freezing.
The third party UCB will be infused the day after infusion of PBSCs.
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Aktiv komparator: Haplo-PBSC+BM group
The BMSCs from the same HID will be infused the day after infusion of PBSCs.
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PBSCs harvest is performed from day 5 of G-CSF to obtain at least 7.0×10^8 total nucleated cells/kg recipient ideal body weight.
BMSCs of donor will be collected and infused at least 0.5×10^8 total nucleated cells/kg recipient ideal body weight the day after PBSCs infusion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sygdomsfri overlevelse (DFS)
Tidsramme: 1 år
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1 år
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Samlet overlevelse (OS)
Tidsramme: 1 år
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1 år
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|
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Tilbagefaldsfrekvens
Tidsramme: 1 år
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1 år
|
|
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The cumulative incidence of hematopoietic engraftment.
Tidsramme: 30 days post-transplantation
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Hematopoietic engraftment includes the time of neutrophil and platelet engraftment.
Neutrophil engraftment was defined as the first of two consecutive days with an absolute neutrophil count in the peripheral blood exceeding 0.5 × 10^9/L and the platelet engraftment was defined as the first of 3 days with an absolute platelet count exceeding 20 × 10^9 /L without transfusion support.
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30 days post-transplantation
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The cumulative incidence of acute graft-versus-host-disease (GVHD)
Tidsramme: 100 days post-transplantation
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Acutue GVHD was defined according to the 1994 consensus conference on acute GVHD grading and graded from I to IV.
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100 days post-transplantation
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The cumulative incidence of chronic GVHD
Tidsramme: 1 year
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Chronic GVHD was graded as mild, moderate and severe according to the national institutes of health consensus development project on criteria for clinical trials in chronic GVHD: the 2014 diagnosis and staging working group report.
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
15. februar 2022
Primær færdiggørelse (Forventet)
30. september 2023
Studieafslutning (Forventet)
30. september 2024
Datoer for studieregistrering
Først indsendt
3. marts 2022
Først indsendt, der opfyldte QC-kriterier
13. marts 2022
Først opslået (Faktiske)
22. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Haplo+Cord vs Haplo-2022
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Ingen
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