Relapsing or refractory acute lymphoblastic leukemia. Acute lymphoblastic leukemia, in relapse
Conditions
Interventions
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 manufactured by Carayakhteh tajhiz azma Co./ For patients over 50 kg: 0.1 to 2.5 in ten t
Sponsors
Carayakhteh Tajhiz Azma Co.
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: boys or girls 2-18 years old Relapsing or refractory CD19+ B-ALL Disease in bone marrow (Blast > 5 percent) Able to withstand the apheresis process to produce a research product as determined by the researcher Life expectancy more than 12 weeks as determined by the researcher Lansky score (16 years) more than 50 percent At least 7 days have passed since the last chemotherapy, excluding maintenance chemotherapy At least 7 days have passed since the last treatment with corticosteroids At least 3 days have passed since using a tyrosine kinase inhibitor (TKI) The patient or the patient's guardian/legal representative should sign the informed consent form for this study. Having potential donor for stem cell transplantation
Exclusion criteria
Exclusion criteria: Presence of active malignancy other than the disease under study Presence of chloroma and leukemic infiltration on MRI, or patients with significant neurologic symptoms (unless alternative therapies lead to neurologic stabilization) History or presence of any CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema Presence of active GVHD (acute GVHD grade 2-4 or chronic extensive), or receiving immunosuppressive therapy to treat or prevent GVHD within 4 weeks before entering the study Radiation therapy within 14 days from the time of enrollment in the study History of Anti-CD19 or Anti-CD20 therapy Donor Lymphocyte Infusion (DLI) or other cellular therapies within 30 days prior to enrollment in the study Acute severe active infection Hepatic dysfunction Renal dysfunction Cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with overall remission rate (ORR) (complete response (CR) or complete remission with incomplete blood count recovery (Cri)). Timepoint: Month 1 and 2-3 after intervention. Method of measurement: Clinical, Bone marrow aspiration.;Event-free survival. Timepoint: Month 1 and 2-3 after intervention. Method of measurement: Clinical, Bone marrow aspiration.;Overall survival. Timepoint: Month 1, and 3 after intervention. Method of measurement: Time calculation from intervention to death from any cause in follow-up and statistical calculation based on survival curve.;Incidence of cytokine release syndrome: grade 3 and 4. Timepoint: Month 1, and 3 after intervention. Method of measurement: Physical examination: Investigation of presence of Fever, Myalgia, hypotension, and Hypoxia requiring respiratory support.;Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4. Timepoint: Month 1, and 3 after intervention. Method of measurement: Relevant physical examination and medical history. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with overall remission rate (ORR) (complete response (CR) or complete remission with incomplete blood count recovery (Cri)). Timepoint: Month 6, and 12 after intervention. Method of measurement: Clinical, Bone marrow aspiration.;Investigation of Minimal residual disease in patient. Timepoint: Month 1, and 2-3 after intervention. Method of measurement: Bone marrow aspiration.;Incidence of cytokine release syndrome: grade 3 and 4. Timepoint: Month 6 and 12 after intervention. Method of measurement: Physical examination: Presence of Fever, Myalgia, hypotension, and Hypoxia requiring respiratory support.;Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4. Timepoint: Month 6, and 12 after intervention. Method of measurement: Relevant physical examination and medical history.;Incidence of tumor lysis syndrome (TLS). Timepoint: Month 1,3,6 and 12 after intervention. Method of measurement: Physical examination and laboratory values: Based on Laboratory data, Clinical signs of hypocalcemia, cardiac arrythmia.;Incidence of leukopenia. Timepoint: Month 1,3,6 and 12 after intervention. Method of measurement: Cell blood count.;Incidence of infection. Timepoint: Month 1,3,6 and 12 after intervention. Method of measurement: Physical examination.;Event-free survival. Timepoint: Month 6 and 12 after intervention. Method of measurement: Clinical, Bone marrow aspiration.;Overall survival. Timepoint: Month 6 and 12 after intervention. Method of measurement: Time calculation from Intervention to death from any cause in follow-up period and statistical calculation based on survival curve. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Behfar
Tehran University of Medical Sciences
Outcome results
None listed