RAdR Regimen for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a combination of four drugs—romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide—can safely treat people with mature T-cell lymphoma, a rare cancer. These cancers often return after standard treatments, and the study aims to provide a new option for those whose previous treatments have failed. Participants should have already tried and not succeeded with standard therapies for T-cell malignancies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are on other investigational drugs or certain medications that affect heart rhythm. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial—romidepsin, CC-486 (5-azacitidine), lenalidomide, and dexamethasone—have been tested for safety in earlier studies.
Romidepsin has been used for other T-cell lymphomas. Studies indicate it can cause side effects related to blood and common reactions like nausea or tiredness, but it is generally considered safe for these conditions.
CC-486 (5-azacitidine) has been tested in patients with similar blood cancers. Some patients needed to adjust their doses due to side effects like low blood counts, though serious side effects are rare but possible.
Lenalidomide is already approved for other T-cell lymphomas. It is generally safe, though some patients might experience side effects like low blood counts or tiredness.
Dexamethasone, a steroid that helps reduce inflammation, is widely used and generally safe, though it might cause side effects like weight gain or mood changes.
Overall, while each drug can cause side effects, they are usually manageable. Researchers will closely monitor participants in this trial to ensure their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the RAdR regimen for T-cell lymphoma because it combines three promising drugs: lenalidomide, CC-486 (5-azacitidine), and romidepsin. Unlike the standard of care, which often involves chemotherapy and immunotherapy, this regimen targets cancer cells through epigenetic modulation and immune system enhancement. CC-486 is an oral form of azacitidine, making it more convenient than traditional injections, while romidepsin, a histone deacetylase inhibitor, offers a novel mechanism by modifying gene expression to inhibit cancer growth. This innovative combination has the potential to be more effective and easier to administer than existing treatments.
What evidence suggests that this trial's treatments could be effective for T-cell lymphoma?
Research has shown that the drug CC-486 (also known as 5-azacitidine) holds potential for treating T-cell lymphomas, with some studies indicating a 75% overall response rate. Lenalidomide has also undergone testing, yielding varying results; about 30% of patients in certain studies experienced partial improvement. Romidepsin, when combined with other treatments, demonstrated a 58% overall response rate. In this trial, participants will receive a combination of these drugs, along with Dexamethasone, in different dosing regimens to evaluate their combined effect. The goal is to achieve better results than using each drug separately.25678
Who Is on the Research Team?
Mark J Roschewski, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults over 18 with relapsed or treatment-resistant mature T-cell malignancies, who have tried at least one line of systemic therapy. They must be able to sign consent, meet specific blood and organ function criteria, agree to contraception use if applicable, and not be pregnant or breastfeeding. Prior tissue samples for study are required unless a new biopsy is agreed upon.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CC-486 (5-azacitidine)
- Dexamethasone
- Lenalidomide
- Romidepsin
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor