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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed / Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed / Refractory B-Cell Non-Hodgkin Lymphoma

The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed / refractory (r / r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r / r) B-cell non-Hodgkin lymphoma (NHL).
Pediatric Leukemia
Phase I/II
Both
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Cyclophosphamide (CTX), Fludarabine (Fludara), KTE-C19, Mesna
Kitko, Carrie
National
Vanderbilt University
02-15-2017
Treatment
VICCPED15143
NCT02625480

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Key Inclusion Criteria for the ALL Cohort - Relapsed or refractory B-precursor ALL defined as one of the following: - Primary refractory disease - Any relapse within 18 months after first diagnosis - Relapsed or refractory disease after 2 or more lines of systemic therapy - Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from stem cell transplant at the time of enrollment - Disease burden defined as at least 1 of the following: - Morphological disease in the bone marrow (> 5% blasts) - Minimal/Measurable Residual Disease (MRD) positive (threshold 10^-4 by flow or Polymerase chain reaction (PCR)) - Individuals with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs - Age ? 21 years and weight ? 6 kg at the time of assent or consent per Institutional Review Board (IRB) guidelines - Note: Individuals with a weight of ? 6 kg to 92% on room air Key Exclusion Criteria for the ALL Cohort - Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis - History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years - History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study - Central nervous system (CNS) involvement and abnormalities: - Any CNS tumor mass by imaging and/or parameningeal mass (cranial and/or spinal) - Presence of central nervous system (CNS)-3 disease, defined as white blood cell (WBC) ? 5/µL in Cerebrospinal Fluid (CSF) with presence of lymphoblasts with or without neurologic symptoms - CNS-2 disease,defined as WBC 92% on room air Key Exclusion Criteria for the NHL Cohort - History of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, breast), or follicular lymphoma (FL) unless disease free for at least 3 years - Prior CD19 targeted therapy other than blinatumomab - History of severe, immediate hypersensitivity reaction attributed to aminoglycosides - Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. - History of HIV infection or acute/chronic active hepatitis B or C infection. Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines - Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by International Bone Marrow Transplant Registry (IBMTR) index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment. - CNS involvement and abnormalities: - Any CNS tumor mass by imaging and/or parameningeal mass (cranial and/or spinal) - Presence of CNS-3 disease, defined as WBC ? 5/µL in CSF with presence of lymphoblasts with or without neurologic symptoms. - Presence of CNS-2 disease defined as WBC

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