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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blinatumomab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blinatumomab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Progression free survival of this group of patients at the end of 2 year | 2 years |
| 100 day adverse events (AE) | non-hematologic adverse events | Day +100 |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse mortality (NRM) | Non-relapse mortality of this group of patients at the end of 6 month | 6 months |
| Relapse rate | Relapse rate of this group of patients at the end of 2 year |
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Inclusion Criteria:
B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
KPS > 60 or ECOG 0-2;
The expected survival time is more than 3 months;
Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
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;
No central nervous system involvement or clinical symptoms after transplantation;
Those who have no serious functional damage to important organs of the body;
Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-28-85422373 | jieji@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
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|
| 2 years |
| Overall survival (OS) | Overall survival of this group of patients at the end of 2 year | 2 years |
| 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 |
| 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 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |