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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

Must not have

- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification Class II), congenital long QT syndrome, or other serious cardiac arrhythmia including 2nd degree atrio ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).

- Patients with a diagnosis of CTCL are excluded from participation in the expansion cohort.

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

No Placebo-Only Group

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.

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.

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 below

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My disease can be measured by specific criteria or shows abnormal T-cells in blood tests.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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My T or NK/T cell cancer has returned or worsened after treatment.

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I am older than 18 years.

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My T or NK/T cell cancer diagnosis has been confirmed by a pathology lab.

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I have ALCL or CD30+ MF/SS and did not respond well to brentuximab vedotin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions or recent major heart events.

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I do not have cutaneous T-cell lymphoma (CTCL).

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My hepatitis B virus load is undetectable with treatment.

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I have a history of serious gut conditions that could affect drug absorption or increase risk of gut side effects.

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I am not pregnant or breastfeeding.

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I am currently receiving treatment for another cancer.

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I have an enlarged heart or heart muscle issues from past treatments or other reasons.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for 6 months, every 3 months for 2 years, every 6 months for 2 years, then annually for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

safety and tolerability

Secondary study objectives

Complete Response Rate

Duration of response (DOR)

Overall Repsonse Rate

+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039

100%

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%

Oedema peripheral

33%

Hyperhidrosis

33%

Alanine aminotransferase increased

33%

Cancer Pain

33%

Akathisia

33%

Hypocalcaemia

33%

Vitreous Floaters

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Lenalidomide

2005

Completed Phase 3

~2240