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

Leukemia, Lymphoid Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075238
• Other study ID #: PT-Blin 1.0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: October 2023
• Source: Sichuan University
• Contact: Jie Ji, MD
• Phone: 86-28-85422373
• Email: jieji[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Recurrence

Intervention

Drug:
• blinatumomab
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.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression free survival of this group of patients at the end of 2 year	2 years
Primary	100 day adverse events (AE)	non-hematologic adverse events	Day +100
Secondary	Non-relapse mortality (NRM)	Non-relapse mortality of this group of patients at the end of 6 month	6 months
Secondary	Relapse rate	Relapse rate of this group of patients at the end of 2 year	2 years
Secondary	Overall survival (OS)	Overall survival of this group of patients at the end of 2 year	2 years
Secondary	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
Secondary	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