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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after completion of study treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Duration of response
HTLV-1 clonality
Human T-cell leukemia virus type 1 (HTLV-1) proviral deoxyribonucleic acid and ribonucleic acid loads
+5 more

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
Positron Emission Tomography
2008
Completed Phase 2
~2240
Cyclophosphamide
1995
Completed Phase 3
~3770
Lenalidomide
2005
Completed Phase 3
~1480
Vincristine Sulfate
2005
Completed Phase 3
~10150
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Etoposide
2010
Completed Phase 3
~2440
Computed Tomography
2017
Completed Phase 2
~2720
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
Lee RatnerPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

Cyclophosphamide; Doxorubicin Hydrochloride; Etoposide; Vincristine Sulfate (Alkylating Agent; Anti-tumor antibiotic; Topoisomerase I inhibitor; Vinca Alkaloid) Clinical Trial Eligibility Overview. Trial Name: NCT04301076 — Phase 1
Adult T-Cell Leukemia/Lymphoma Research Study Groups: Treatment (lenalidomide, EPOCH)
Adult T-Cell Leukemia/Lymphoma Clinical Trial 2023: Cyclophosphamide; Doxorubicin Hydrochloride; Etoposide; Vincristine Sulfate Highlights & Side Effects. Trial Name: NCT04301076 — Phase 1
Cyclophosphamide; Doxorubicin Hydrochloride; Etoposide; Vincristine Sulfate (Alkylating Agent; Anti-tumor antibiotic; Topoisomerase I inhibitor; Vinca Alkaloid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301076 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you outline other experiments that have studied the potential of Lenalidomide?

"Lenalidomide was initially assessed in 1997 at Spectrum Health Hospital - Butterworth Campus, and to date there have been 2607 trials on the medication concluded. There are presently 1624 ongoing studies with a considerable amount of them occuring in Uniondale, New jersey."

Answered by AI

Has the federal agency sanctioned lenalidomide for medical use?

"Lenalidomide's safety was scored a 1 out of 3 due to the limited data available from Phase 1 trials, which provides minimal information on efficacy and safety."

Answered by AI

Are there vacancies available for volunteers in this clinical experiment?

"Clinicaltrials.gov confirms that enrollment is ongoing for this medical trial, which was initially posted on June 15th 2020 and modified as recently as September 29th 2022."

Answered by AI

How widely dispersed is the implementation of this research in America?

"Presently, 13 sites are hosting this medical trial. These sites span from Uniondale, New york to Montvale and several other locations in-between. To best facilitate the process for participants, it is strongly recommended that they select a site as close to their home as possible."

Answered by AI

Is this trial a pioneering effort or has it been conducted previously?

"To date, 1624 active trials for lenalidomide have been conducted in 80 nations and 3276 cities. This medication was initially tested as part of a 1997 study sponsored by Alfacell which included 300 patients and culminated with Phase III drug approval. Since then, 2607 trials have taken place across the world."

Answered by AI

What medical conditions is Lenalidomide typically prescribed as a treatment for?

"Lenalidomide can be utilized to manage prostate cancer, pheochromocytomas, and ulcerative colitis."

Answered by AI

What is the maximum number of participants accepted into this experiment?

"Affirmative. According to the clinicaltrials.gov website, this experiment is accepting applicants as of now - first being posted on June 15th 2020 and most recently updated on September 29th 2022. It aims to recruit 30 test subjects from 13 distinct sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATL)
2021. "Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04301076.
~12 spots leftby Dec 2025
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