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NCT04447027 · ClinicalTrials.gov registry record · Phase 1
Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04447027: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04447027 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447027, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test 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. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatm
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Romidepsin
- DIAGNOSTIC_TEST EKG
- DRUG CC-486 (5-azacitidine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2025-12-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04447027
The ClinicalTrials.gov registry entry for NCT04447027 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT04447027 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04447027 about?
NCT04447027 is a clinical study titled "Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies". Background: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effe...
What is the current status of trial NCT04447027?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-12-17. Estimated completion is 2025-12-17.
What interventions are being tested in trial NCT04447027?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Romidepsin (DRUG), EKG (DIAGNOSTIC_TEST), CC-486 (5-azacitidine) (DRUG).
Who is sponsoring clinical trial NCT04447027?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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