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Alkylating Agent; Anti-tumor antibiotic; Topoisomerase I inhibitor; Vinca Alkaloid

Lenalidomide + EPOCH Chemotherapy for Adult T-Cell Leukemia-Lymphoma

Phase 1

Recruiting

Led By Lee Ratner

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Age ≥ 18 years

Must not have

Patients with urinary outflow obstruction

Patients with any form of demyelinating disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after completion of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment regimen that includes the drug lenalidomide. Lenalidomide is already approved for other types of cancer, but its use in this particular cancer is experimental. The goal of the trial is to find the best dose of lenalidomide to give with standard chemotherapy drugs, and to learn about any side effects of this combination treatment.

Who is the study for?

This trial is for adults with T-cell leukemia-lymphoma, including those untreated or with one prior chemo cycle. Participants must have adequate organ function, no serious infections, and a life expectancy over 12 weeks. HIV-positive patients on effective therapy can join; hepatitis C must be treated. Pregnant women cannot participate, and all participants must use birth control.

What is being tested?

The trial tests Lenalidomide's effectiveness when added to EPOCH chemotherapy (etoposide, prednisone, vincristine sulfate [Oncovin], cyclophosphamide, doxorubicin hydrochloride) in treating adult T-cell leukemia-lymphoma. It aims to find the best dose of Lenalidomide that works well with standard chemo.

What are the potential side effects?

Lenalidomide may cause side effects like blood clots and birth defects if taken during pregnancy. Chemotherapy drugs can lead to hair loss, nausea/vomiting, fatigue, increased risk of infection due to low blood cell counts and potential damage to heart or nerves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My heart condition does not severely limit my daily activities.

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I am able to become pregnant and will use birth control and have a negative pregnancy test.

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I do not have any serious infections requiring treatment right now.

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I have chronic hepatitis B but it's under control with medication.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

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I have been treated with AZT, IFN, bexarotene, or mogamulizumab before.

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My cancer is a type of ATLL and tests positive for CD2, CD3, or CD4.

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I have confirmed HTLV infection through tests.

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I am not on any other cancer treatments during this study.

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My kidney function tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty urinating due to a blockage.

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I have a condition that affects the protective covering of my nerves.

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I do not have any unmanaged ongoing illnesses.

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I have been treated with IMiDs for my ATLL.

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I cannot take aspirin or certain blood thinners.

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I have recovered from major side effects of previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Duration of response

HTLV-1 clonality

Human T-cell leukemia virus type 1 (HTLV-1) proviral deoxyribonucleic acid and ribonucleic acid loads

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, EPOCH)Experimental Treatment10 Interventions

INDUCTION THERAPY: Patients receive lenalidomide PO QD on days 1-14 of 21 day cycles or days 1-21 or 1-28 of 28 day cycles. Patients receive doxorubicin hydrochloride IV continuously on days 1-4, vincristine sulfate IV continuously on days 1-4, etoposide IV continuously on days 1-4, prednisone PO on days 1-5, and cyclophosphamide IV over 1-4 hours on day 5. Treatment repeats every 21 or 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients with CR, PR, or SD may receive up to 2 additional cycles of lenalidomide, doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone, and cyclophosphamide at the discretion of the investigator and/or up to an additional 2 years of lenalidomide in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy at baseline and as clinically indicated. Patients undergo PET/CT or CT, tissue and blood sample collection throughout.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Positron Emission Tomography

2011

Completed Phase 2

~2200