Clinical trial · Interventional
Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphoid | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blinatumomab | Drug | Blinatumomab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- blinatumomab
- 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.
- interventionNames
- Drug: blinatumomab
Primary outcomes (2)
- measure
- Progression free survival (PFS)
- timeFrame
- 2 years
- description
- Progression free survival of this group of patients at the end of 2 year
- measure
- 100 day adverse events (AE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
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