search
Back to results

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

Primary Purpose

B-cell Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Blinatumomab
Conventional therapy
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first affiliated hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Blinatumomab arm

Conventional therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall survival (OS)
The time from randomization to death from any cause.

Secondary Outcome Measures

The proportion of patients with negative minimal residual disease (MRD)
Negative MRD is defined as below 10-4 by flow cytometry.
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.
Cumulative incidence of relapse (CIR)
From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.

Full Information

First Posted
September 26, 2022
Last Updated
September 26, 2022
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Fujian Medical University Union Hospital, Zhongda Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First People's Hospital of Changzhou, Wuxi People's Hospital, First Affiliated Hospital of Wannan Medical College
search

1. Study Identification

Unique Protocol Identification Number
NCT05559450
Brief Title
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Fujian Medical University Union Hospital, Zhongda Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First People's Hospital of Changzhou, Wuxi People's Hospital, First Affiliated Hospital of Wannan Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blinatumomab arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Other
Arm Description
Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Intervention Description
Blinatumomab will be bridged to conventional BUCY conditioning regimen.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Control group will be given conventional BUCY conditioning regimen.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time from randomization to death from any cause.
Time Frame
From the 1st day to the 720th days after enrollment.
Secondary Outcome Measure Information:
Title
The proportion of patients with negative minimal residual disease (MRD)
Description
Negative MRD is defined as below 10-4 by flow cytometry.
Time Frame
From the 1st day to the 720th days after enrollment.
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
From the 1st day to the 720th days after enrollment.
Title
Cumulative incidence of relapse (CIR)
Description
From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.
Time Frame
From the 1st day to the 720th days after enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huizhu Kang, MD
Phone
18761925608
Email
khz11826@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Zhou, MD
Phone
15606133002
Email
zhoumeng@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Han, MD/PhD
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Zhang, PhD
Phone
15606133002
Email
zhangxiang@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29358182
Citation
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. Erratum In: Blood. 2019 Jun 13;133(24):2625.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs