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L'essai clinique NCT06861348 (ZJU-HSCT-INO) pour Leucémie lymphocytaire aiguë est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Effectiveness and Safety of InO±DLI for Relapsed B-ALL/LBL After Allo-HSCT (ZJU-HSCT-INO) Phase II 23 Immunothérapie Essai pivot Anticorps monoclonal Survie globale

Pas encore en recrutement
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L'essai clinique NCT06861348 (ZJU-HSCT-INO) est conçu pour étudier le traitement de Leucémie lymphocytaire aiguë. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2025, avec un objectif de 23 participants. Dirigée par First Affiliated Hospital of Zhejiang University, l'étude devrait être terminée d'ici le 30 avril 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 6 mars 2025.
Résumé succinct
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...Afficher plus
Titre officiel

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

Pathologies
Leucémie lymphocytaire aiguë
Autres identifiants de l'étude
  • ZJU-HSCT-INO
  • IIT20240086C-X1
Numéro NCT
NCT06861348
Date de début (réel)
2025-03-01
Dernière mise à jour publiée
2025-03-06
Date de fin (estimée)
2027-04-30
Inscription (estimée)
23
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Mots clés
Inotuzumab Ozogamicin
Donor Lymphocyte Infusion
Relapsed B cell Acute Lymphoblastic Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIno±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...Afficher plus
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 ...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
14 Years
Sexes éligibles
Tous
  1. Aged 14-65 years, male or female;
  2. Participants with CD22 positive B-ALL/LBL who relapsed after allo-HSCT from a related or unrelated donor (regardless of CD22 expression);
  3. ECOG physical status score 0~3, Karnofsky score ≥70;
  4. 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;
  5. Creatinine clearance rate≥50 mL/min (estimate by Cockcroft-Gault Equation);
  6. Liver function: alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 3×upper limit of normal (ULN), and total bilirubin ≤ 2×ULN;
  7. Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography;
  8. Estimated life expectancy >3 months;
  9. Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.

  1. Allergic or with a history of serious adverse reactions to drugs or drugs with similar chemical structure in this study;
  2. Women who are pregnant or breastfeeding, as well as those who are unwilling to take effective contraceptive measures;
  3. 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;
  4. Severe pulmonary disorders (obstructive or restrictive ventilation disorder);
  5. Severe liver function impairment: ALT, AST, or TBIL is more than 3 times higher than the upper limit of normal value (ULN);
  6. 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;
  7. Participants with active infection or active bleeding who were deemed intolerance to InO treatment by the investigators;
  8. A history of new thrombosis, embolism, cerebral hemorrhage or other diseases within one year before enrollment;
  9. 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;
  10. A history of major organ surgery within the past six weeks;
  11. Drug abuse or chronic alcohol abuse that may affect the study results;
  12. Participants with a history of organ transplantation other than HSCT (except BMT);
  13. Other situations identified by the investigator as unsuitable to participate in the study.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
Partie responsable de l'étude
Yi Luo, Investigateur principal, Clinical Professor, First Affiliated Hospital of Zhejiang University
Contact central de l'étude
Contact: Yi Luo, M.D., +8613666609126, [email protected]
Contact: Honghu Li, M.D., +8618158514785, [email protected]
1 Centres de l'étude dans 1 pays
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Yi Luo, M.D., Contact, 86-13666609126, [email protected]
Honghu Li, M.D., Contact, +8618158514785, [email protected]
Yi Luo, Investigateur principal