Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06111625

Statut inconnu

Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

Interventionnel

Phase 2

West China Hospital of Sichuan University

Sponsor: Sichuan University

Dernière synchronisation : 1 novembre 2023
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.

Catégorie de traitement

Anticorps monoclonaux

Mutations requises

Aucun

Essai commencé

10 septembre 2023

Dernière mise à jour par le sponsor

1 novembre 2023

Achèvement estimé

31 août 2024

Contact de l'étude

Nom:N/A

E-mail:N/A

Téléphone:N/A

Éligibilité

Critères d'inclusion

1. patients diagnosed with B-ALL;

2. patients with age ≥ 16 years;

3. Availability of both pre- and post-transplantation disease status records.

Critères d'exclusion

1. administration of blinatumomab therapy for more than 14 days;

2. patients with leukemia burden ≥ 10% before initiation of treatment;

3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;

4. patients with central nervous system leukemia.

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Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire20

Bras et interventions

Bras

Interventions

Type : Experimental

Description : Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion. Patients underwent myeloablative conditioning therapy consisting of fludarabine-and-busulfan-based regimen. Peripheral stem cells from HLA-matched sibling donors (MSD), matched unrelated donors (MUD), or haploidentical donors (HID) were reinfused two days after conditioning. Follow-up examinations were scheduled at +1, +2, +3, +4, +6, +9, +12, +18, and +24 months post-transplant.

Interventions :

blinatumomab

Mesures des résultats

Mesures des résultats primaires

Progression free survival (PFS)2 years

Progression free survival of this group of patients at the end of 2 years

Mesures des résultats secondaires

Cumulative incidence of acute graft versus host disease (aGVHD)Day +100

Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100

Overall survival (OS)2 years

Overall survival of this group of patients at the end of 2 years

Relapse rate2 years

Relapse rate of this group of patients at the end of 2 years

Cumulative incidence of chronic graft versus host disease (cGVHD)2 years

Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 years

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Sites d'essai

Cette étude compte 1 site d'essai

West China Hospital of Sichuan University

Chengdu, Sichuan, CN

Nom:Jie Ji, MD

E-mail:jieji@scu.edu.cn

Téléphone:86-28-85422370

Nom:Jie Ji, MD

E-mail:jieji@scu.edu.cn

Téléphone:86-28-85422370

Recrutement en cours

Chengdu, Sichuan, 610044 CN

West China Hospital of Sichuan University

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