Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)

Conditions

• Acute Adult T-Cell Leukemia/Lymphoma
• Adult T-Cell Leukemia/Lymphoma
• Chronic Adult T-Cell Leukemia/Lymphoma
• HTLV-1 Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo tissue and blood sample collection
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Computed Tomography — PROCEDURE
  Undergo PET/CT or CT
• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Etoposide — DRUG
  Given IV
• Lenalidomide — DRUG
  Given PO
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Prednisone — DRUG
  Given PO
• Vincristine Sulfate — DRUG
  Given IV

Study Details

This phase I trial studies the side effects and best dose of lenalidomide when given together with usual combination chemotherapy (etoposide, prednisone, vincristine sulfate \[Oncovin\], cyclophosphamide, and doxorubicin hydrochloride \[hydroxydaunorubicin hydrochloride\], or "EPOCH") in treating adult T-cell leukemia-lymphoma. Lenalidomide may help shrink or slow the growth of adult T-cell leukemia-lymphoma. Drugs used in chemotherapy, such as etoposide, vincristine, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving lenalidomide and the usual combination chemotherapy may work better in treating adult T-cell leukemia-lymphoma compared to the usual combination chemotherapy alone.

Key Dates

First listed

Mar 9, 2020

Start date

Aug 31, 2021

Status verified

Jul 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (lenalidomide, EPOCH)
  See Detailed Description.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to the end of induction therapy ]

Locations (19)

Find similar trials in Atlanta, GA

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