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

NCT05559450 | Unknown Phase 2

• 1 other identifier: 2022019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from randomization to death from any cause.

  From the 1st day to the 720th days after enrollment.

Secondary Outcomes (3)

• The proportion of patients with negative minimal residual disease (MRD)

  From the 1st day to the 720th days after enrollment.

• Progression-Free Survival (PFS)

  From the 1st day to the 720th days after enrollment.

• Cumulative incidence of relapse (CIR)

  From the 1st day to the 720th days after enrollment.

Study Arms (2)

Blinatumomab arm

EXPERIMENTAL

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.

Drug: Blinatumomab

Conventional therapy

OTHER

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

Other: Conventional therapy

Interventions

Blinatumomab DRUG

Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Blinatumomab arm

Conventional therapy OTHER

Control group will be given conventional BUCY conditioning regimen.

Conventional therapy

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Patients are combined with infection or other complications that can not tolerate chemotherapy.
• Patients are suffering from central nervous system/solitary extramedullary leukemia.
• Patients are considered as tumer progression.
• Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
• Pregnant and lactating women will not be included.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Fujian Medical University Union Hospital: collaborator
• Zhongda Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The First People's Hospital of Changzhou: collaborator
• Wuxi People's Hospital: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (1)

The first affiliated hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29358182 BACKGROUND

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yue Han, MD/PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huizhu Kang, MD

CONTACT

18761925608; khz11826@sina.com

Meng Zhou, MD

CONTACT

15606133002; zhoumeng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: September 29, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)