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N-Acetylcysteine for Lymphoma

Phase 1
Recruiting
Led By Connie Batlevi, MD, PhD, MS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Patients who will receive axicabtagene ciloleucel for treatment of lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing the safety of a new drug, N-AC, when given with Yescarta to people with lymphoma. Different doses of N-AC will be tested to find the highest dose that is well tolerated by participants.

Who is the study for?
This trial is for adults with lymphoma who are about to receive Yescarta (CAR T-cell therapy). They must be over 18, have a performance status that allows daily activity, and their blood counts and organ functions need to meet specific levels. People allergic to N-Acetylcysteine cannot participate.Check my eligibility
What is being tested?
The study is testing the safety of different doses of N-Acetylcysteine (N-AC) when given alongside Yescarta in lymphoma patients. The goal is to find the highest dose of N-AC that has few or mild side effects.See study design
What are the potential side effects?
Potential side effects from N-AC may include nausea, vomiting, rash, and rarely more serious reactions like difficulty breathing if an allergy exists. Side effects will vary based on the dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will be treated with axicabtagene ciloleucel for my lymphoma.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of N-AC

Side effects data

From 2015 Phase 3 trial • 302 Patients • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Arthropod bite
1%
Road traffic accident
1%
Alcohol abuse
1%
Cellulitis
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants with Lymphoma, Cohort 3Experimental Treatment1 Intervention
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 II: Participants with Lymphoma, Cohort 2Experimental Treatment1 Intervention
The second cohort in the study will be treated at 50% of that target dose level
Group III: Participants with Lymphoma, Cohort 1Experimental Treatment1 Intervention
The first dose escalation cohort in the study will be treated at 25% of that target dose level
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,866 Total Patients Enrolled
155 Trials studying Lymphoma
8,707 Patients Enrolled for Lymphoma
Connie Batlevi, MD, PhD, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Lymphoma
100 Patients Enrolled for Lymphoma
Gunjan Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

N-Acetylcysteine Clinical Trial Eligibility Overview. Trial Name: NCT05081479 — Phase 1
Lymphoma Research Study Groups: Participants with Lymphoma, Cohort 1, Participants with Lymphoma, Cohort 2, Participants with Lymphoma, Cohort 3
Lymphoma Clinical Trial 2023: N-Acetylcysteine Highlights & Side Effects. Trial Name: NCT05081479 — Phase 1
N-Acetylcysteine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081479 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key indications for N-Acetylcysteine?

"N-Acetylcysteine has been known to successfully treat corneal ulceration, as well as a range of other ailments including acute rhinitis, acetaminophen poisoning, and various corneal diseases."

Answered by AI

Has the Federal Drug Administration (FDA) sanctioned N-Acetylcysteine?

"Considering the scant evidence available, our team has assigned N-Acetylcysteine a 1 on the safety scale due to it being in Phase 1 of its clinical trials."

Answered by AI

Are individuals with the relevant condition able to join this investigation?

"Affirmative. According to the clinicaltrials.gov website, this experiment is actively recruiting participants since its inception on 12th of August 2021 and most recent update taking place 24th of August 2022. 32 patients must be sourced from 1 separate medical centre in order for it to succeed."

Answered by AI

Has N-Acetylcysteine been previously tested as part of a clinical trial?

"Currently, there are 38 active clinical trials for N-Acetylcysteine with 7 studies in Phase 3. Primarily based in New york State, these 44 trial sites span the United States."

Answered by AI

How many subjects are being monitored in this clinical experiment?

"Affirmative. The clinicaltrial.gov portal reveals that this experiment, which was first inaugurated on December 8th 2021, is actively enrolling participants. A total of 32 individuals need to be enrolled from one medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of N-Acetylcysteine (N-AC)in People Receiving CAR T-cell Therapy for Lymphoma
2021. "A Study of N-Acetylcysteine (N-AC)in People Receiving CAR T-cell Therapy for Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081479.
~12 spots leftby Oct 2025
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