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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559450
• Other study ID #: 2022019
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2022
• Est. completion date: January 2026

Study information

• Verified date: December 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Huizhu Kang, MD
• Phone: 18761925608
• Email: khz11826[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Blinatumomab
Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Other:
• Conventional therapy
Control group will be given conventional BUCY conditioning regimen.

Locations

Country	Name	City	State
China	The first affiliated hospital of Soochow University	Suzhou	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	First Affiliated Hospital of Wannan Medical College, Fujian Medical University Union Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First People's Hospital of Changzhou, Wuxi People's Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Gökbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Brüggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum in: Blood. 2019 Jun 13;133(24):2625. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	The time from randomization to death from any cause.	From the 1st day to the 720th days after enrollment.
Secondary	The proportion of patients with negative minimal residual disease (MRD)	Negative MRD is defined as below 10-4 by flow cytometry.	From the 1st day to the 720th days after enrollment.
Secondary	Progression-Free Survival (PFS)	It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.	From the 1st day to the 720th days after enrollment.
Secondary	Cumulative incidence of relapse (CIR)	From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.	From the 1st day to the 720th days after enrollment.