A Study of N-Acetylcysteine (N-AC)in People Receiving CAR T-cell Therapy for Lymphoma

• Status: Not yet recruiting
• Trial end date: 2023-10-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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