Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 17, 2020

Primary Completion Date

July 1, 2024

Study Completion Date

May 15, 2026

Conditions
Cutaneous T-Cell LymphomaMature T-cell MalignanciesPeripheral T-Cell LymphomaRelapsed/ Refractory T-cell Malignancies
Interventions
DRUG

Romidepsin

Romidepsin (12mg/ m\^2) will be administered on days 1 and 10 of each cycle through a peripheral or central intravenous catheter for 6 cycles.

DRUG

Lenalidomide

Lenalidomide will be administered by oral intake in a dose-escalation with a starting dose of 5mg daily, a second dose level of 10mg daily, a third dose level at 15mg daily, and a fourth dose level at 20mg daily on days -7 to day 10 of first cycle. After the second cycle, lenalidomide will be given from day 1 to day 10 in each cycle for up to 6 cycles.

DRUG

CC-486 (5-azacitidine)

CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 6 cycles.

DRUG

Dexamethasone

Dexamethasone, 40mg, by mouth (PO), will be given on days 1 and 10 of each cycle.

DIAGNOSTIC_TEST

EKG

Screening

PROCEDURE

Bone Marrow Aspiration/Biopsy

Baseline, end of treatment and disease progression, and Day 30 (+7).

DIAGNOSTIC_TEST

MRI

Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.

PROCEDURE

Lumbar Puncture

Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.

DIAGNOSTIC_TEST

TTE

Screening

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH