Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observation study 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:
• Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.
Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.
Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blin-PTCY | Post-transplant cyclophosphamide is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. |
| |
| Blin-ATG | Antithymocyte globulin is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. |
| |
| Control | Patients don't take blinatumomab treatment after transplantation. |
| 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| T cell receptor expression | T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ) | before blinatumomab treatment , 6 months and 1 year |
| B cell receptor expression | B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ) | before blinatumomab treatment , 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| T cell subsets count | T cell subsets count including CD3+, CD4+, CD8+, CD19+, Treg, memory and cytotoxic T cells | before blinatumomab treatment , 6 months and 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510808 | blinatumomab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
peripheral blood
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |