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DNA Methyltransferase Inhibitor
RAdR Regimen for T-Cell Lymphoma
Phase 1
Waitlist Available
Led By Milos Miljkovic, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease must be measurable with at least one measurable lesion by RECIL 2017 or mSWAT criteria, or have an abnormal clonal T-cell population detectable by peripheral blood flow cytometry
- Serum Creatinine <= 1.5 mg/dL OR Creatinine Clearance >= 60 mL/min/1.73 m^2 as calculated by direct measurement of 24-hour urine for creatinine clearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Awards & highlights
Study Summary
This trial is testing if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of combining romidepsin (IV), CC-486 (oral), dexamethasone (oral), and lenalidomide (oral) in treating T-cell malignancies that haven't responded well to other treatments. Participants will undergo regular physical exams, imaging scans every six weeks, blood tests during treatment, and follow-ups post-treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion through IV like inflammation at the site or allergic responses; digestive issues from oral medications; changes in blood cell counts requiring monitoring; fatigue; risk of infection due to immune system impact.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease can be measured by specific criteria or shows abnormal T-cells in blood tests.
Select...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
Select...
My T or NK/T cell cancer has returned or worsened after treatment.
Select...
I am older than 18 years.
Select...
My T or NK/T cell cancer diagnosis has been confirmed by a pathology lab.
Select...
I have ALCL or CD30+ MF/SS and did not respond well to brentuximab vedotin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually
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 (MTD)
safety and tolerability
Secondary outcome measures
Complete Response Rate
Duration of response (DOR)
Overall Repsonse Rate
+2 moreSide effects data
From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039100%
Dysgeusia
100%
Leukopenia
100%
Thrombocytopenia
100%
Lymphopenia
100%
Neutropenia
100%
Nausea
100%
Vomiting
100%
Pyrexia
100%
Fatigue
100%
Decreased appetite
100%
Peripheral Sensory neuropathy
67%
Diarrhoea
67%
Anaemia
67%
Lip dry
67%
Haemoglobin decreased
67%
Weight decreased
67%
Blood phosphorus increased
67%
Hypotension
67%
Insomnia
33%
Hypokalaemia
33%
Alanine aminotransferase increased
33%
Akathisia
33%
Oedema peripheral
33%
Hypocalcaemia
33%
Hyperhidrosis
33%
Vitreous Floaters
33%
Cancer Pain
33%
Biliary colic
33%
Abdominal pain upper
33%
Dental caries
33%
Gastritis
33%
Hypothermia
33%
Influenza like illness
33%
Non-cardiac chest pain
33%
Hypermagnesaemia
33%
Hyperuricaemia
33%
Blood alkaline phosphatase increased
33%
Blood urea increased
33%
Somnolence
33%
Rash macular
33%
Hypoxia
33%
Arthralgia
33%
Back Pain
33%
Musculoskeletal stiffness
33%
Osteoarthritis
33%
Periarthritis
33%
Nasopharyngitis
33%
Influenza
33%
Upper respiratory tract infection
33%
Long QT syndrome
33%
Contusion
33%
Procedural Pain
33%
Phlebitis
33%
Pollakiuria
33%
Headache
33%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Romidepsin 9mg/m^2
Phase 1: Romidepsin 14mg/m^2
Phase 2: Romidepsin 14mg/m^2
Total: Romidepsin 14mg/m^2
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2 - Experimental Treatment: Dose ExpansionExperimental Treatment4 Interventions
Lenalidomide by oral intake at MTD on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, romidepsin at 12mg/m2 by IV infusion on Day 1 and 10 and dexamethasone at 40mg by oral intake on days 1 and 10 of each cycle
Group II: 1- Experimental Treatment: Dose EscalationExperimental Treatment4 Interventions
Lenalidomide by oral intake at escalating doses of 5, 10, 15, or 20 mg/day on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, romidepsin at 12mg/m2 by IV infusion on Day 1 and 10 and dexamethasone at 40mg by oral intake on days 1 and 10 of each cycle, to determine MTD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romidepsin
2011
Completed Phase 2
~790
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,609 Total Patients Enrolled
Milos Miljkovic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
928 Total Patients Enrolled
Kevin C Conlon, M.D.Principal InvestigatorNational Cancer Institute (NCI)
10 Previous Clinical Trials
1,048 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment in the last 2 weeks.I have been treated with two out of lenalidomide, romidepsin, and 5-azacitidine.I do not have serious heart conditions or recent major heart events.I have not taken rifampin or strong CYP3A4 inhibitors and inducers in the last 2 weeks.I do not have cutaneous T-cell lymphoma (CTCL).My blood pressure is controlled and has been stable on medication for at least a month.You have had allergic reactions or known sensitivities to drugs similar to lenalidomide, romidepsin, and 5-azacitidine.My hepatitis B virus load is undetectable with treatment.I am HIV positive, on treatment, and my viral load is undetectable.I have a history of serious gut conditions that could affect drug absorption or increase risk of gut side effects.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I can provide a tumor sample or am willing to have a biopsy if needed.My disease can be measured by specific criteria or shows abnormal T-cells in blood tests.I am not currently on medications that significantly affect my heart's rhythm.I can care for myself, but my daily activities might be limited due to my illness.My organs and bone marrow are working well.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am not pregnant or breastfeeding.I am a woman of childbearing age and not pregnant.You have serious medical conditions, including mental health issues like recent thoughts of self-harm or suicidal behavior. You also have abnormal lab results that could increase the risks of participating in the study or make it hard to understand the study's results.I do not have any uncontrolled illnesses or social situations that would stop me from following the study's requirements.I am currently receiving treatment for another cancer.My T or NK/T cell cancer has returned or worsened after treatment.I have an enlarged heart or heart muscle issues from past treatments or other reasons.I am older than 18 years.My T or NK/T cell cancer diagnosis has been confirmed by a pathology lab.I have ALCL or CD30+ MF/SS and did not respond well to brentuximab vedotin.You are not currently taking any other experimental medications.
Research Study Groups:
This trial has the following groups:- Group 1: 2 - Experimental Treatment: Dose Expansion
- Group 2: 1- Experimental Treatment: Dose Escalation
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.
What results is this experiment attempting to demonstrate?
"With observation over 21 days, this clinical trial has the primary objective of gauging safety and tolerability. Secondary objectives include assessing Complete Response Rate with a 95% confidence interval, Duration of response (DOR) also measured within a 95% confidence interval, as well as Progression-free survival evaluated in conjunction with that same threshold."
Answered by AI
What other examinations have been conducted on Romidepsin?
"Currently, 711 studies are being conducted with Romidepsin. Of these live trials, 169 of them have advanced to Phase 3. Although most experiments take place in Mishawaka, Indiana; there is a global network of 25776 medical sites running different tests for this medication."
Answered by AI
Has the U.S. Food and Drug Administration (FDA) sanctioned Romidepsin for public use?
"Our research team gave Romidepsin a score of 1 because the early-phase clinical trial data indicates limited efficacy and safety information."
Answered by AI
Are there any available opportunities for volunteers to take part in this study?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting subjects with the first posting being made on December 17th 2020 and a recent update occurring on October 14th 2022. 30 participants need to be sourced from one medical facility for successful completion of the trial."
Answered by AI
What is the scope of participants in this research initiative?
"Affirmative. The clinicaltrials.gov website indicates that recruitment is currently underway for this medical trial, which was originally posted on December 17th 2020 and revised on October 14th 2022. 30 participants are sought at a single location."
Answered by AI
What medical condition typically necessitates Romidepsin?
"Romidepsin is the most common treatment for ophthalmia, sympathetic. This medication may also help patients manage branch retinal vein occlusion, macular edema and provide another option after two systemic chemotherapy regimens have failed."
Answered by AI
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