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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2026-10-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with Lymphoma, Cohort 1

The first dose escalation cohort in the study will be treated at 25% of that target dose level

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients \<45kg will be adjusted to weight based dosing.

Participants with Lymphoma, Cohort 2

The second cohort in the study will be treated at 50% of that target dose level

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients \<45kg will be adjusted to weight based dosing.

Participants with Lymphoma, Cohort 3

The third cohort in the study will be treated at 100% of that target dose level only if no DLTs are seen at lower doses.

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients \<45kg will be adjusted to weight based dosing.

Interventions

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N-Acetylcysteine

N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients \<45kg will be adjusted to weight based dosing.

Intervention Type DRUG

Other Intervention Names

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N-AC

Eligibility Criteria

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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.