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Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

Primary Purpose

Leukemia, Lymphoid

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
blinatumomab
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphoid

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT; Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF); KPS > 60 or ECOG 0-2; The expected survival time is more than 3 months; Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator; Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation; No central nervous system involvement or clinical symptoms after transplantation; Those who have no serious functional damage to important organs of the body; Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose. Exclusion Criteria: Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; Poor graft function (PGF) occurred after allo-HSCT; Combined with other malignant tumors and require treatment; Active GVHD; Have a history of allergy to Chidamide; Pregnant or lactating females; Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C; History of prolonged QT syndrome; Patients considered by other researchers to be unsuitable for this study

Sites / Locations

  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

blinatumomab

Arm Description

Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
100 day adverse events (AE)
non-hematologic adverse events

Secondary Outcome Measures

Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 month
Relapse rate
Relapse rate of this group of patients at the end of 2 year
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Cumulative incidence of acute graft versus host disease (aGVHD)
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT06075238
Brief Title
Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
Official Title
Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blinatumomab
Arm Type
Experimental
Arm Description
Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
Intervention Type
Drug
Intervention Name(s)
blinatumomab
Intervention Description
The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Progression free survival of this group of patients at the end of 2 year
Time Frame
2 years
Title
100 day adverse events (AE)
Description
non-hematologic adverse events
Time Frame
Day +100
Secondary Outcome Measure Information:
Title
Non-relapse mortality (NRM)
Description
Non-relapse mortality of this group of patients at the end of 6 month
Time Frame
6 months
Title
Relapse rate
Description
Relapse rate of this group of patients at the end of 2 year
Time Frame
2 years
Title
Overall survival (OS)
Description
Overall survival of this group of patients at the end of 2 year
Time Frame
2 years
Title
Cumulative incidence of acute graft versus host disease (aGVHD)
Description
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time Frame
Day +100
Title
Cumulative incidence of chronic graft versus host disease (cGVHD)
Description
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT; Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF); KPS > 60 or ECOG 0-2; The expected survival time is more than 3 months; Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator; Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation; No central nervous system involvement or clinical symptoms after transplantation; Those who have no serious functional damage to important organs of the body; Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose. Exclusion Criteria: Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; Poor graft function (PGF) occurred after allo-HSCT; Combined with other malignant tumors and require treatment; Active GVHD; Have a history of allergy to Chidamide; Pregnant or lactating females; Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C; History of prolonged QT syndrome; Patients considered by other researchers to be unsuitable for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Ji, MD
Phone
86-28-85422373
Email
jieji@scu.edu.cn
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

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