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

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05559450

Collaborator

Fujian Medical University Union Hospital (Other), Zhongda Hospital (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), The First People's Hospital of Changzhou (Other), Wuxi People's Hospital (Other), First Affiliated Hospital of Wannan Medical College (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
B-cell Acute Lymphoblastic Leukemia	Drug: Blinatumomab Other: Conventional therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Blinatumomab Blinatumomab will be bridged to conventional BUCY conditioning regimen.
Other: Conventional therapy Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.	Other: Conventional therapy Control group will be given conventional BUCY conditioning regimen.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Blinatumomab

Blinatumomab will be bridged to conventional BUCY conditioning regimen.

Other: Conventional therapy

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

Other: Conventional therapy

Control group will be given conventional BUCY conditioning regimen.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [From the 1st day to the 720th days after enrollment.]
The time from randomization to death from any cause.

Secondary Outcome Measures

The proportion of patients with negative minimal residual disease (MRD) [From the 1st day to the 720th days after enrollment.]
Negative MRD is defined as below 10-4 by flow cytometry.
Progression-Free Survival (PFS) [From the 1st day to the 720th days after enrollment.]
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.
Cumulative incidence of relapse (CIR) [From the 1st day to the 720th days after enrollment.]
From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.