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

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

Q: Has the federal agency sanctioned lenalidomide for medical use?

<p><a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a>'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.</p>

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

Patients must have histologically or cytologically confirmed CD2+, CD3+, or CD4+ acute, lymphoma or poor-risk chronic subtypes of ATLL including previously untreated or previously treated individuals who have received no more than 1 previous cycle of combination chemotherapy. If the patient has a cycle of EPOCH prior to entering on the study, doses of EPOCH during the first cycle with lenalidomide should be altered as described for cycle 2 EPOCH modifications below

Absolute neutrophil count >= 1,000/mm^3 unless decreased due to bone marrow (BM) involvement with lymphoma

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 2 years after completion of study treatment

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Adult T-Cell Leukemia/Lymphoma
Human T-cell Leukemia Virus-1 Infection

Eligibility Criteria

Inclusion Criteria

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

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You can participate if you have been treated with certain medications like AZT, IFN, bexarotene, or mogamulizumab. You can also participate if you had stable disease after receiving chemotherapy in the past and are at high risk of the disease coming back.

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You have cancer that has spread to the brain or spinal fluid, but if your doctor believes that you don't need immediate treatment for it, you can still participate in the trial.

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

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

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 Treatment6 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 also 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Etoposide

2010

Completed Phase 3

~2440

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Lenalidomide

2005

Completed Phase 3

~1480

Vincristine Sulfate

2005

Completed Phase 3

~10120

Prednisone

2014

Completed Phase 4

~2370

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,492 Previous Clinical Trials

41,267,549 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

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 e 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.

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