A Phase I Study Assessing the Addition of Lenalidomide to the Usual Combination Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma

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Full Title

A Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) (NCI 10335) (CIRB)

Purpose

The goal of this study is to find the best dose of lenalidomide that can be given together with the usual combination chemotherapy in adults with HTLV-associated T-cell leukemia-lymphoma. The usual chemotherapy consists of the drugs etoposide, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin hydrochloride) and is known as EPOCH. Lenalidomide may help shrink or slow the growth of adult T-cell leukemia-lymphoma.

Giving lenalidomide with EPOCH may work better against adult T-cell leukemia-lymphoma than EPOCH alone. Lenalidomide and prednisone are taken orally (by mouth) and the other medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HTLV-associated adult T-cell leukemia-lymphoma.
  • At least 4 weeks must pass between the completion of prior cancer therapy and receipt of the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven Horwitz at 646-608-3725.

Protocol

21-140

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04301076