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Die klinische Studie NCT06861348 (ZJU-HSCT-INO) für Akute lymphozytische Leukämie ist noch nicht rekrutierend. 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
Effectiveness and Safety of InO±DLI for Relapsed B-ALL/LBL After Allo-HSCT (ZJU-HSCT-INO) Phase 2 23 Immuntherapie Zulassungsstudie Monoklonale Antikörper Gesamtüberleben
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Die klinische Studie NCT06861348 (ZJU-HSCT-INO) untersucht Behandlung im Zusammenhang mit Akute lymphozytische Leukämie. Diese interventionsstudie der Phase 2 hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2025 geplant, bis 23 Teilnehmer aufgenommen werden. Durchgeführt von First Affiliated Hospital of Zhejiang University wird der Abschluss für 30. April 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. März 2025 aktualisiert.
Kurzbeschreibung
B cell acute lymphoblastic leukemia (B-ALL)/Lymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of B-lineage precursor cells. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potential curable therapy for ALL, especially for high-risk ALL patients. However, post-HSCT recurrence is the primary cause of transplant failure and salvage...Mehr anzeigen
Offizieller Titel
Effectiveness and Safety of Inotuzumab Ozogamicin±Donor Lymphocyte Infusion for Relapsed B Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma After Allogeneic Hematopoietic Stem Cell Transplantation：Phrase II, Multicenter Study
Erkrankungen
Akute lymphozytische LeukämieWeitere Studien-IDs
- ZJU-HSCT-INO
- IIT20240086C-X1
NCT-Nummer
Studienbeginn (tatsächlich)
2025-03-01
Zuletzt aktualisiert
2025-03-06
Studienende (vorauss.)
2027-04-30
Geplante Rekrutierung
23
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Noch nicht rekrutierend
Stichwörter
Inotuzumab Ozogamicin
Donor Lymphocyte Infusion
Relapsed B cell Acute Lymphoblastic Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Donor Lymphocyte Infusion
Relapsed B cell Acute Lymphoblastic Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellIno±DLI regimen 1\. InO induction：the first cycle: 0.8mg/m2, intravenous infusion, d1; 0.5 mg/m2, intravenous infusion, d8, d15. 2.InO consolidation：If CR/CRi was reached after induction, the second cycle :0.5mg/m2, intravenous infusion, d1, d8, d15; If CR/CRi is not reached, Cycle 2 :0.8mg/m2, IV infusion, d1; 0.5 mg/m2, intravenous infusion, d8, d15. 3. DLI: CD3 positive cells 1x10\^7/kg; DLI indication: no previous grade III-IV a...Mehr anzeigen | Inotuzumab Ozogamicin±Donor Lymphocyte Infusion Participants will receive Ino±DLI regimen:
* ① InO induction dose: the first cycle: 0.8mg/m2, intravenous infusion, d1; 0.5 mg/m2, intravenous infusion, d8, d15;
* ② If CR/CRi was reached after induction, the second cycle :0.5mg/m2, intravenous infusion, d1, d8，d15; If CR/CRi is not reached, Cycle 2 :0.8mg/m2, IV infusion, d1; 0.5 mg/m2, intravenous infusion, d8, d15;
* ③DLI dose: CD3 positive cells 1x10\^7/kg; DLI ...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
complete remission rate (CRR) | CR was defined as bone marrow (BM) lymphoblasts≤5%, no evidence of active disease, and complete recovery of peripheral blood counts (platelet count \>100×109/L, absolute neutrophil count \>1×109/L); CRi was defined as BM lymphoblasts ≤5%, no evidence of active disease, and incomplete recovery of peripheral blood counts (platelet count\>50×109/L and absolute neutrophil count \>0.5×109/L). CR rate after InO treatment will be recorded. | 1 month after InO treatment |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Duration of remission (DOR) | The period from the first evaluation of CR to the first evaluation of PD or death of any cause. | 2 year |
Overall survival (OS) | The period from the first infusion to any cause of death. | 2 years |
Progression-free survival (PFS) | The period from the day when the participant receives Ino treatment to the first recorded disease progression (whether treated or not) or death of any cause, which occurs first. | 2 years |
Cumulative incidence of disease relapse or progression | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. | 2 year |
Cumulative incidence of transplant-related nonrelapse mortality (NRM) | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. | 2 year |
Incidence of Treatment Related adverse events (AEs) | Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) assessed by NCI-CTCAE v5.0 criteria. | 2 year |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
- Aged 14-65 years, male or female;
- Participants with CD22 positive B-ALL/LBL who relapsed after allo-HSCT from a related or unrelated donor (regardless of CD22 expression);
- ECOG physical status score 0~3, Karnofsky score ≥70;
- No active grade III/IV graft-versus-host disease (GvHD) or any active liver GvHD, no history of venous occlusive disease (VOD); No active GvHD and no previous history of VOD;
- Creatinine clearance rate≥50 mL/min (estimate by Cockcroft-Gault Equation);
- Liver function: alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 3×upper limit of normal (ULN), and total bilirubin ≤ 2×ULN;
- Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography;
- Estimated life expectancy >3 months;
- Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.
- Allergic or with a history of serious adverse reactions to drugs or drugs with similar chemical structure in this study;
- Women who are pregnant or breastfeeding, as well as those who are unwilling to take effective contraceptive measures;
- Severe cardiac dysfunction: left ventricular ejection fraction (LVEF) <60%; Or severe arrhythmia: a history of a clinically significant corrected interval (QTc) prolongation (male >450ms; female>470 ms), ventricular tachycardia, atrial fibrillation, second degree atrioventricular block; myocardial infarction and coronary heart disease with clinical symptoms requiring medical treatment within one year before enrollment;
- Severe pulmonary disorders (obstructive or restrictive ventilation disorder);
- Severe liver function impairment: ALT, AST, or TBIL is more than 3 times higher than the upper limit of normal value (ULN);
- Severe renal impairment: serum Cr is more than 2 times higher than the upper limit of normal (ULN); Or 24-hour urinary creatinine clearance <50ml/min;
- Participants with active infection or active bleeding who were deemed intolerance to InO treatment by the investigators;
- A history of new thrombosis, embolism, cerebral hemorrhage or other diseases within one year before enrollment;
- Participants suffer from known or other mental disorders that investigators are unable to obtain informed consent and may interfere with their ability to comply with research requirements;
- A history of major organ surgery within the past six weeks;
- Drug abuse or chronic alcohol abuse that may affect the study results;
- Participants with a history of organ transplantation other than HSCT (except BMT);
- Other situations identified by the investigator as unsuitable to participate in the study.
First Affiliated Hospital of Zhejiang UniversityVerantwortliche Partei
Yi Luo, Hauptprüfer, Clinical Professor, First Affiliated Hospital of Zhejiang University
Zentrale Studienkontakte
Kontakt: Yi Luo, M.D., +8613666609126, [email protected]
Kontakt: Honghu Li, M.D., +8618158514785, [email protected]
1 Studienstandorte in 1 Ländern
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Yi Luo, M.D., Kontakt, 86-13666609126, [email protected]
Honghu Li, M.D., Kontakt, +8618158514785, [email protected]
Yi Luo, Hauptprüfer