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The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:
B-cell acute lymphoblastic leukemia (B-ALL), as the most common type of pediatric tumor, is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood. Also, relapse and refractory B-ALL (R/R B-ALL) is the main reason of global mortality due to the constraints of combination chemotherapy.
Over the past few years, substantial advancements have been made in treatment of ALL, specifically in the R/R context. Chimeric antigen receptor T (CAR-T) cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface. CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of r/r B-ALL. In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with R/R B-ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 CAR-T treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 CAR T cell therapy | Biological | Anti-CD19 CAR-T cell therapy for R/R B-ALL pediatric patients. For patients 50 kg and less: 0.2 to 5 in ten to the power of six live CAR+ T cells per kilogram of body weight/ For patients over 50 kg: 0.1 to 2.5 in ten to the power of eight live CAR+ T cells (without considering weight). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi) | First month and 2-3 months after intervention | |
| Overall survival | First month and 3 months after intervention | |
| Incidence of cytokine release syndrome: grade 3 and 4 | First month and 3 months after intervention | |
| Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4 | First month and 3 months after intervention | |
| Event-free survival | First month and 2-3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi) | 6 months and 12 months after intervention | |
| Investigation of Minimal residual disease in patient | First month and 2-3 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Setayesh Sadeghi | Contact | +989124779968 | sadeghi.setayesh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric cell and gene therapy research center, Children medical center | Recruiting | Tehran | Tehran Province | 1419733151 | Iran |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
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| Incidence of cytokine release syndrome: grade 3 and 4 | 6 months and 12 months after intervention |
| Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4 | 6 months and 12 months after intervention |
| Incidence of tumor lysis syndrome (TLS) | Months 1, 3, 6, and 12 after the intervention |
| Incidence of leukopenia | Months 1, 3, 6, and 12 after the intervention |
| Incidence of infection | Months 1, 3, 6, and 12 after the intervention |
| Event-free survival | 6 months and 12 months after intervention |
| Overall survival | 6 months and 12 months after intervention |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |