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

NCT ID: NCT05559450

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-01-31

Brief 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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blinatumomab arm

On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: DRUG

Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Conventional therapy

Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.

Group Type: OTHER

Conventional therapy

Intervention Type: OTHER

Control group will be given conventional BUCY conditioning regimen.

Interventions

Blinatumomab

Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Intervention Type: DRUG

Conventional therapy

Control group will be given conventional BUCY conditioning regimen.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role: collaborator

Wuxi People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

HAN Yue

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yue Han, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The first affiliated hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huizhu Kang, MD

Role: CONTACT

khz11826@sina.com

18761925608

Meng Zhou, MD

Role: CONTACT

zhoumeng@suda.edu.cn

15606133002

Facility Contacts

Xiang Zhang, PhD

Role: primary

zhangxiang@suda.edu.cn

15606133002

References

Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann 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.

Reference Type: BACKGROUND

PMID: 29358182 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022019

Identifier Type: -

Identifier Source: org_study_id