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Clinical Trials in China / NCT06075238
Starting soon Phase 2

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

NCT06075238 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan University
Phase
Phase 2
Started
2023-10-01
Last updated
2023-10-10

Condition(s) studied

Leukemia, Lymphoid

Investigational drug(s) / intervention(s)

blinatumomab

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.

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06075238 on ClinicalTrials.gov ↗ ← All trials in China