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
Verified date | October 2023 |
Source | Sichuan University |
Contact | Jie Ji, MD |
Phone | 86-28-85422373 |
jieji[@]scu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan University |
China,
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 |
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