Relapse/Refractory B-cell Acute Lymphoblastic Leukemia
Conditions
Brief summary
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: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
Detailed description
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.
Interventions
BIOLOGICALanti-CD19 CAR T cell therapy
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).
Sponsors
Kara Yakhteh Tajhiz Azma Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL * Presence of disease in the bone marrow * Able to tolerate the apheresis process * Life expectancy > 12 weeks * Lansky or Karnofsky score > 50% * At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids * Informed consent * Having potential donor for stem cell transplantation
Exclusion criteria
* Presence of active malignancy other than the disease under study * Chloroma and leukemic infiltration on MRI or significant neurological symptoms * Any CNS disorder * Presence of active GVHD * Radiation therapy within last 14 days * History of Anti-CD19 or Anti-CD20 therapy * Donor lymphocyte injection or other cell therapy methods within the last 30 days * Presence of severe active infection * Organ dysfunction
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of leukopenia | Months 1, 3, 6, and 12 after the intervention |
| Incidence of infection | Months 1, 3, 6, and 12 after the intervention |
| 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 |
| Overall survival | 6 months and 12 months after intervention |
| Event-free survival | 6 months and 12 months after intervention |
| Investigation of Minimal residual disease in patient | First month and 2-3 months after intervention |
| 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 |
Countries
Iran
Contacts
Primary ContactSetayesh Sadeghi
Outcome results
None listed