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Itacitinib + CAR T-Cell Therapy for Lymphoma
Phase 2
Recruiting
Led By Michael Jain, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27months
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new medicine to treat DLBCL before receiving CAR-T cell therapy.
Who is the study for?
Adults with diffuse large B-cell lymphoma planning to receive CAR-T cell therapy at Moffitt Cancer Center, who can't have stem cell transplants due to active lymphoma. They must understand and consent to the study, meet certain blood test criteria, agree to use contraception, and not be pregnant or nursing. Excluded are those with prior CAR-T therapy, severe itacitinib reactions, strong CYP3A4 inhibitors usage, uncontrolled infections or cardiac disease, unstable arrhythmias on medication within 2 weeks of screening.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of taking a daily oral dose of itacitinib before receiving axicabtagene ciloleucel (axi-cel) CAR-T cell therapy for treating diffuse large B-cell lymphoma. It aims to see if pre-modulating with itacitinib improves outcomes.See study design
What are the potential side effects?
Itacitinib may cause side effects like infection risk increase due to immune system suppression; gastrointestinal issues such as nausea or diarrhea; liver enzyme changes; and potential blood clotting problems. The CAR T-cell therapy could lead to cytokine release syndrome (flu-like symptoms), neurological events (confusion or seizures), low blood cells counts increasing infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Incidence of Severe Cytokine Release Syndrome (CRS)
Incidence of Severe Immune efflector cell Associated Neurotoxicity Syndrome (ICANS)
Overall Response Rate
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pre-Modulation TreatmentExperimental Treatment2 Interventions
Participants will receive itacitinib 200 mg PO QD beginning at time of apheresis approximately 4-6 weeks prior to CAR-T-cell therapy and will continue until Day 30 (30 Days Post-CAR-T-cell therapy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,468 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,138 Total Patients Enrolled
Michael Jain, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong CYP3A4 inhibitors.I currently have an untreated infection.I have active or chronic hepatitis B.I am currently taking long-term steroids or immunosuppressants.My heart rhythm problem hasn't stabilized with treatment in the last 2 weeks.I am 18 years or older and can give informed consent.I agree to use birth control during the study.I still have side effects from previous cancer treatments.I have previously undergone CAR T-cell therapy.I have a serious or unmanaged heart condition.I am eligible for a specific immune therapy for my lymphoma.I have a history of immune or inflammatory diseases affecting my brain or spinal cord.I have a history of hepatitis C virus infection.I cannot swallow or keep down oral medication.I have been diagnosed with DLBCL and plan to receive treatment at Moffitt Cancer Center.I can take care of myself and perform daily activities.I am a woman who cannot become pregnant.I cannot have a stem cell transplant due to my active lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-Modulation Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pre-Modulation Treatment obtained regulatory approval from the FDA?
"Pre-Modulation Treatment received a score of 2 on Power's safety scale, as Phase 2 trials provide some evidence for its safety but no concrete proof yet that it is efficacious."
Answered by AI
Are there any available vacancies to join this research project?
"Indeed, clinicaltrials.gov confirms that this medical experiment is still seeking participants. The trial was initially uploaded on February 23rd 2023 and most recently revised on the following day. 27 volunteers are needed from a single enrolment location."
Answered by AI
How many individuals have participated in this clinical experiment?
"Affirmative, data hosted on clinicaltrials.gov shows that this medical trial is still identifying potential participants. It was first published on February 23rd 2023 and last updated a day later. The research team are currently looking for 27 individuals from 1 site."
Answered by AI
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