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Die klinische Studie NCT07499284 für Aplastic Anaemia ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Multicenter, Randomized, Open-Label Study of Haplo-Cord HSCT for the Treatment of Aplastic Anemia 224 Randomisiert Offene Studie Gesamtüberleben
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07499284 ist eine interventionsstudie zur Untersuchung von Aplastic Anaemia und hat den Status offene rekrutierung. Die Studie startete am 1. Oktober 2025 und soll 224 Teilnehmer aufnehmen. Durchgeführt von The First Affiliated Hospital of Soochow University ist der Abschluss für 30. September 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. März 2026 aktualisiert.
Kurzbeschreibung
Aplastic anemia (AA) is a bone marrow failure disorder characterized by pancytopenia and hypoplastic bone marrow caused by the decrease of hematopoietic stem cells. The pathogenesis of AA is complex and involves an abnormal hematopoietic microenvironment, hematopoietic stem cell/progenitor cell deficiencies and immunity disorders.
Currently, the standard treatment for AA includes immunosuppressive therapy (IST) base...
Mehr anzeigenAusführliche Beschreibung
This study is designed to assess the safety and efficacy of haplo-cord HCT versus haplo HCT in patients with aplastic anemia, with particular emphasis on factors associated with treatment outcome and adverse events.
Offizieller Titel
A Multicenter, Randomized, Open-Label Study to Analyze the Efficacy of Unrelated Cord Blood Combined With Haploidentical Stem Cell Transplantation in Patients With Aplastic Anemia
Erkrankungen
Aplastic AnaemiaWeitere Studien-IDs
- SOOCHOW-WXJ-2025-1075
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-01
Zuletzt aktualisiert
2026-03-30
Studienende (vorauss.)
2028-09-30
Geplante Rekrutierung
224
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Haplo-Cord HCT
Haplo HCT
Aplastic Anemia
Haplo HCT
Aplastic Anemia
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellExperimental group: 112 patients with aplastic anemia undergo haplo-cord HCT | Haploidentical hematopoietic cell transplantation combined with unrelated cord blood stem cells 1\. Donor Stem Cells Infusion (Haploidentical hematopoietic cell transplantation combined with unrelated cord blood stem cells) Day 0: Intravenous infuse a single unit of unrelated cord blood stem cells( TNC≤2×10⁷/kg, CD34+ cells≤0.8×10⁵/kg, HLA match≥5/10 loci, and either matched ABO type or a cord blood unit of type O). This is followed, 6 hours after the cord blood infusion, by the infusion of donor haploidentical...Mehr anzeigen |
Aktives VergleichspräparatComparator group: 112 patients with aplastic anemia undergo haplo HCT | Haploidentische hämatopoetische Zelltransplantation 1\. Donor Stem Cell Infusion (Haploidentical hematopoietic cell transplantation) Day 0: Intravenous infuse of donor haploidentical stem cells (TNC≥8×10⁸/kg, CD34+ cells≥4.0×10⁶/kg, and HLA match≥6/12 loci). 2. Conditioning Regimen: Day -7 to Day -6: Busulfan (Bu) 3.2mg/kg/day; Day -5 to Day -2: Cyclophosphamide (CTX) 160-200mg/kg. 3. Graft-versus-Host Disease Prophylaxis Regimen: Starting on the day before transplant...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Overall survival rate | We estimated OS from the time of transplant until the date of death of any cause or last follow-up for patients still alive. | within 1 year following HSCT |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The cumulative incidence of neutrophil engraftment and platelet engraftment | Neutrophil and platelet engraftment is defined as the first occurence of 3 consecutive days with an absolute neutrophil count of at least 0.5x10⁹/L and a platelet count of over 20x10⁹/L/L for 7 consecutive days without transfusion support. | on day 28+7 following HSCT |
Disease Free Survival | We defined DFS as the time from the initiation of transplant to the occurrence of any treatment failure event (including graft failure or disease relapse requiring therapeutic intervention), or death from any cause, whichever occurred first. Patients who were alive and event-free at the last follow-up were censored. | within 1 year following HSCT |
The cumulative incidence and grade of graft-versus-host disease (GVHD) | Graft-versus-host disease (GvHD) is a medical complication following the receipt of transplanted tissue from a genetically diferent person. | within 1 year following HSCT |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
(1)Aged ≥14 years. (2) Patients diagnosed with aplastic anemia meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Management of Aplastic Anemia (2024 Edition). (3) Patients who were eligible for allogeneic bone marrow or peripheral blood hematopoietic stem cell transplantation in accordance with the Clinical Application and Management Specifications for Allogeneic Hematopoietic Stem Cell Transplantation Technology (2022 Edition). (4) The patient understands the study protocol and voluntarily signs the informed consent form. (5) Life expectancy of ≥3 months; (6) Pre-transplant assessment meets the following criteria: Karnofsky Performance Status (KPS) score≥70, Eastern Cooperative Oncology Group Performance Status (ECOG PS) score≤2, and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score≤2.
(1)Patients with aplastic anemia secondary to malignancy treatment or those with concurrent active malignancy. (2) Women who are pregnant or lactating. (3) Patients with psychiatric or psychological disorders that preclude adequate compliance with the treatment protocol. (4) Patients with positive serologic testing for any of the four major infectious diseases (hepatitis B, hepatitis C, syphilis, HIV). (5) Patients with systemic infection or localized severe infection requiring active antimicrobial therapy. (6) Patients with significant dysfunction of major organs (e.g., heart, lung, liver, kidney). (7) Patients with a known allergy or hypersensitivity to any drug or component used in this study. (8) Patients who are currently participating in or plan to participate in any other clinical trial. (9) Any other condition deemed by the investigator to render the patient unsuitable for study participation.
The First Affiliated Hospital of Soochow UniversityZentrale Studienkontakte
Kontakt: Xiaojin Wu, +8613057493105, [email protected]
Kontakt: Depei Wu, +8613951102021, [email protected]
4 Studienstandorte in 1 Ländern
Jiangsu
Hematology Department, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China 215006, China
Offene Rekrutierung
Suzhou Hongci Hematology Hospital, Suzhou, Jiangsu, China 215006, China
Offene Rekrutierung
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China 221006, China
Offene Rekrutierung
Zhejiang
The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China 310006, China
Offene Rekrutierung