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Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma
Description
The purpose of this study is to test the safety of N-AC when given in combination with Yescarta to people with lymphoma. This study will test different doses of N-AC to find the highest dose that causes few or mild side effects in participants.
Trial Eligibility
Inclusion Criteria: * Patients must be 18 years of age or older * Patients who will receive axicabtagene ciloleucel for treatment of lymphoma * Patients must have adequate end organ function to be eligible for this study as defined by the following criteria: * ECOG performance status 0-2 * Hematologic function with ANC ≥ 1000, Hgb ≥ 8, Plt ≥ 50k unless there is disease related hematologic toxicity * Renal function with CrCr ≥ 40 ml/min or Cr ≤ 1.5 x ULN * Hepatic function with ALT/AST ≤ 2.5 x ULN, TBili ≤ 1.5 x ULN. Exclusion Criteria: * Patients with known allergy to N-AC
Study Info
Organization
Memorial Sloan Kettering Cancer Center
Primary Outcome
Maximum tolerated dose of N-AC
Interventions
Locations Recruiting
Memorial Sloan Kettering Cancer Center
United States, New York, New York
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