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Romidepsin + Parsaclisib for Lymphoma
Study Summary
This trial is testing a new combination of drugs to see if it's more effective than standard treatment for T-cell lymphomas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 88 Patients • NCT02018861Trial Design
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Who is running the clinical trial?
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- I have been treated with a PI3K inhibitor before.I have not had any other cancer in the last 2 years, with some exceptions.I have a significant history of liver problems.I have recently used medication that weakens my immune system.My brain or spinal cord disease is not under control.I cannot swallow pills or have major stomach problems.I am 18 years old or older.I have been diagnosed with PTCL or CTCL through a biopsy.My cancer is at least stage IB and affects more than 10% of my body or is a type that has spread to my lymph nodes or other areas.I stopped all cancer treatments at least 1 week ago.I do not have any major health issues apart from my current condition.I have not received a live vaccine in the last 30 days.I can understand and am willing to sign a consent form.I am not taking strong CYP3A4 inhibitors or inducers.My condition is mycosis fungoides with large cell transformation.I can take care of myself and perform daily activities.My PTCL cancer returned or didn't respond after treatment, including brentuximab for ALCL.My CTCL cancer has worsened after at least 2 skin treatments or 1 body-wide treatment.My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.I am currently taking medication for an infection.My condition worsened while on romidepsin or soon after stopping it.
- Group 1: Treatment (romidepsin, parsaclisib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Parsaclisib been given the green light by the Food and Drug Administration?
"Parsaclisib's safety rating is 1 on a scale of 1-3 due to its position in Phase 1 trials, where only scant evidence exists for both efficacy and security."
Is recruitment for this trial still open?
"Affirmative. According to the data hosted on clinicaltrials.gov, this research project is currently looking for participants; it was initially posted on September 1st 2021 and updated most recently on April 6th 2022. The trial needs 20 patients from one single medical facility."
How many individuals have participated in this experiment?
"Affirmative. Clinicaltrials.gov data verifies that this study is actively seeking out participants, with the initial posting being on September 1st 2021 and the most recent update occurring April 6th 2022. The trial aims to enroll 20 patients at a single site location."
Is this the inaugural study of its type?
"As of now, Parsaclisib is the subject of 34 ongoing studies in 28 countries and 148 cities. The original clinical trial for this drug was conducted by Celgene Corporation back in 2012- it included 37 participants and ultimately achieved Phase 1 drug approval status. Since then, a total of 52 experiments have been concluded."
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