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

Phase 2

Not yet recruiting

• Conditions: Leukemia, Lymphoid
• Interventions: Drug: blinatumomab

• Registration Number: NCT06075238
• Lead Sponsor: Sichuan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;

2. Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);

3. KPS > 60 or ECOG 0-2;

4. The expected survival time is more than 3 months;

5. Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;

6. 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;

7. No central nervous system involvement or clinical symptoms after transplantation;

8. Those who have no serious functional damage to important organs of the body;

9. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;

10. 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

1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
3. 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;
4. Poor graft function (PGF) occurred after allo-HSCT;
5. Combined with other malignant tumors and require treatment;
6. Active GVHD;
7. Have a history of allergy to Chidamide;
8. Pregnant or lactating females;
9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
10. Patients with active chronic hepatitis B or active hepatitis C;
11. History of prolonged QT syndrome;
12. Patients considered by other researchers to be unsuitable for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blinatumomab	blinatumomab	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years	Progression free survival of this group of patients at the end of 2 year
100 day adverse events (AE)	Day +100	non-hematologic adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China