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Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL
The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).
Details
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 30 |
| Start date | 2015-06-11 |
| Completion | 2024-08 |
Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Hepatosplenic T-cell Lymphoma
- Peripheral T-cell Lymphoma
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IA Mycosis Fungoides/Sezary Syndrome
- Stage IB Mycosis Fungoides/Sezary Syndrome
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IIA Mycosis Fungoides/Sezary Syndrome
Interventions
- romidepsin
- lenalidomide
- laboratory biomarker analysis
Primary outcomes
- Objective Response Rate (ORR), as Defined Per Cheson Criteria — Assessed after cycles 3 and 6, then every 6 months up to 3 years
The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.
Countries
United States