Loading clinical trials...

Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

NCT05559450•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

Detailed Description

High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
•2. ECOG score is 0-2.
•3. Expecting life span is more than 6 months.
•4. Patients are free from severe organ dysfunction.

Exclusion Criteria

•1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \>2.5mg/ dL or blood Creatinine clearance rate \< 30ml/min.
•2. Patients are combined with infection or other complications that can not tolerate chemotherapy.
•3. Patients are suffering from central nervous system/solitary extramedullary leukemia.
•4. Patients are considered as tumer progression.
•5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
•6. Pregnant and lactating women will not be included.

Locations (1)

The first affiliated hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

February 1, 2022

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2026

Last Updated

September 29, 2022

Enrollment

ESTIMATED participants

Conditions

B-cell Acute Lymphoblastic Leukemia

Interventions

Blinatumomab

DRUG

Conventional therapy

OTHER

Contacts

Huizhu Kang, MD

CONTACT

18761925608 khz11826@sina.com

Meng Zhou, MD

CONTACT

15606133002 zhoumeng@suda.edu.cn

Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

NCT07429461

B-Cell Acute Lymphoblastic Leukemia

View study

RECRUITING

Long-term Follow up Local Registry Study of Kymriah in South Korea

NCT06785818

B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

View study

RECRUITINGPHASE1

Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

Inclusion Criteria

Exclusion Criteria

Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

Long-term Follow up Local Registry Study of Kymriah in South Korea

Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia