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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Leukemia, Lymphoid

Intervention / Treatment
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* Drug: blinatumomab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blinatumomab<br>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. | Drug: blinatumomab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Progression free survival of this group of patients at the end of 2 year | 2 years | 
| 100 day adverse events (AE) | non-hematologic adverse events | Day +100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-relapse mortality (NRM) | Non-relapse mortality of this group of patients at the end of 6 month | 6 months | 
| Relapse rate | Relapse rate of this group of patients at the end of 2 year | 2 years | 
| Overall survival (OS) | Overall survival of this group of patients at the end of 2 year | 2 years | 
| 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 | 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 | 2 years |