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Pembrolizumab + Romidepsin for Lymphoma
Study Summary
This trial is testing pembrolizumab, an immunotherapy, in combination with romidepsin, a cancer growth inhibitor, to treat participants with peripheral T-cell lymphoma that has come back or does not respond to treatment.
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.Trial Design
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Who is running the clinical trial?
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- I am currently on medication for an infection.I have not received a live vaccine in the last 30 days.I have had or currently have lung inflammation treated with steroids.I have not used any experimental drugs or devices in the last 4 weeks.I am at least 18 years old.My PTCL is visible on scans and is larger than 1.5cm.I agree to provide a recent biopsy sample of my tumor.I have active brain metastases or cancer in the lining of my brain.I have been treated for an autoimmune disease in the last 2 years.I agree to follow the study's rules for birth control.I have a type of peripheral T-cell lymphoma or mycosis fungoides with measurable disease.I have an immune system disorder or am taking high-dose steroids or other drugs that weaken my immune system.I have a history of HIV or active Hepatitis B or C.I have a tumor or lymph node that is at least 1.5cm big.I have ALK+ ALCL and cannot or have not used chemotherapy or brentuximab.I have taken a pregnancy test within the last 72 hours and it was negative.My skin lymphoma has returned or didn't respond to treatment, and it's aggressive with significant lymph node involvement.I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.My recent tests show my organs are functioning well.My condition did not improve after at least one treatment.I am willing to use birth control as required by the study.I have had a stem cell transplant from a donor.I am not taking strong drugs that affect liver enzyme CYP3A4.I have no other cancers needing treatment in the last 3 years.I have an active tuberculosis infection.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I am able to care for myself and perform daily activities.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
- Group 1: Treatment (romidepsin, pembrolizumab)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What ailments can be alleviated by using romidepsin and pembrolizumab in combination?
"Romidepsin and pembrolizumab are used to treat multiple malignant neoplasms, as well as microsatellite instability high diseases that have advanced beyond chemotherapy and unresectable melanomas."
What other exploratory investigations have been conducted concerning the effects of romidepsin and pembrolizumab?
"Presently, there are 928 clinical trials running on the effectiveness of Treatment (romidepsin, pembrolizumab) with 124 currently in Phase 3. Though Houston Texas functions as a major hub for research into this treatment, it can be accessed at 35822 different locations across the world."
Are there currently any openings for participants in this clinical trial?
"This clinical trial is not currently open for enrolment. It was first listed on November 14th 2017 and has been edited most recently on January 30th 2023. Should you wish to pursue alternative studies, there are 2606 medical trials recruiting anaplastic large cell lymphoma patients and 928 active applications evaluating the efficacy of romidepsin or pembrolizumab treatments."
What is the scale of participation in this research endeavor?
"At present, this clinical trial is not accepting new participants. This study was first added to the database on November 14th 2017 and its last update occurred on January 30th 2023. For those seeking similar trials, there are 2606 active studies involving anaplastic large cell lymphoma and 928 related investigations testing out treatments such as romidepsin and pembrolizumab that can still be joined."
What aims are hoped to be achieved through this trial?
"This clinical trial is planned to run for up to three years and aims to measure dose-limiting toxicity (Phase I). Secondary objectives include complete response, overall survival, and progression-free survival. Response will be evaluated using Lugano Revised Response Criteria, ISCL for Research and EORTC criteria while summary statistics of continuous variables are gathered. Fisher's exact test is used to determine the correlation between two categorical variables; Wilcoxon rank sum tests analyze differences in continuous values among patient groups; Kaplan–Meier method estimates CR/OR rates with 95% confidence intervals as well as overall & PFS survivals."
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