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Alkylating agents

Lenalidomide + EPOCH-R for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Kathryn A Lurain, M.D.

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

Able to take aspirin 81mg orally daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin

Any KSHV-positive aggressive B cell lymphomas, such as primary effusion lymphoma (PEL), and KSHV-associated large cell lymphoma that is pathologically confirmed by the NCI Laboratory of Pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post end of treatment

Awards & highlights

Study Summary

This trial is testing a new treatment for primary effusion lymphoma (PEL). Eligible participants will take lenalidomide pills for 10 days, followed by DA-EPOCH-R as intravenous infusions and filgrastim and methotrexate injections. Screening tests, physical exams, and blood, urine, and stool tests will be conducted throughout the study.

Who is the study for?

Adults with primary effusion lymphoma (PEL) or KSHV-associated large cell lymphoma can join this trial. They must have measurable or assessable lymphoma, any HIV status, and be able to take daily aspirin or a substitute. Women of childbearing age must test negative for pregnancy and use two forms of birth control; men must use condoms. Participants cannot have had certain other cancer treatments recently, severe illnesses that could interfere with the study, poor organ function related to conditions other than their lymphoma, or known allergies to similar drugs.Check my eligibility

What is being tested?

The trial is testing lenalidomide pills combined with DA-EPOCH-R chemotherapy given through a catheter over several days in cycles lasting 21 days each. Most participants will undergo six cycles. Additional medications like filgrastim and methotrexate are also part of the treatment regimen. The effectiveness of this combination therapy against PEL is being evaluated.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, blood disorders such as low white blood cell counts increasing infection risk, fatigue, digestive issues like nausea and vomiting from chemotherapy drugs used in DA-EPOCH-R regimen; lenalidomide may cause birth defects if taken during pregnancy.

Eligibility Criteria

Inclusion Criteria

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

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I can take aspirin daily or a substitute if I'm allergic.

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My lymphoma is KSHV-positive and confirmed by pathology.

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I can perform daily activities, but my health limits me to varying degrees.

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My lymphoma can be measured or assessed by tests.

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My HIV status is positive or negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(Phase I) Maximum tolerated dose of DA-EPOCH_R2

(Phase II) Overall survival in treatment-naive patients with primary effusion lymphoma treated with DA-EPOCH-R2

Secondary outcome measures

HIV

lenalidomide PK

response rates and progression-free survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment7 Interventions

Lenalidomide, Rituximab, Prednisone, Etopiside, Doxorubicin, Vincristine and Cyclophosphamide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine

2003

Completed Phase 4

~2910

Cyclophosphamide

1995

Completed Phase 3

~3770

Prednisone

2014

Completed Phase 4

~2370

Doxorubicin

2012

Completed Phase 3

~7940

Lenalidomide

2005

Completed Phase 3

~1480

Rituximab

1999

Completed Phase 4

~1880

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,869 Total Patients Enrolled

6 Trials studying Primary Effusion Lymphomas

1,227 Patients Enrolled for Primary Effusion Lymphomas

Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02911142 — Phase 1 & 2

Primary Effusion Lymphomas Research Study Groups: 1

Primary Effusion Lymphomas Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02911142 — Phase 1 & 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02911142 — Phase 1 & 2

Frequently Asked Questions

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

To what maladies does Lenalidomide typically bring relief?

"Lenalidomide is a therapeutic option for patients suffering from leukemia, ophthalmia, sympathetic conditions and lung cancer - especially if the patient has already gone through two prior systemic chemotherapy regimens."

Answered by AI

What other investigations have been conducted in relation to Lenalidomide?

"Presently, there are 1,609 Lenalidomide trials underway with 351 of them in the final phase. The epicentre for these studies is Mishawaka, Indiana; however, it can be found at 60,539 medical centres across the world."

Answered by AI

What does the research team hope to accomplish with this clinical trial?

"Aimed to be achieved within the span of 12 months, this clinical trial aims to gauge overall survival in treatment-naive patients with primary effusion lymphoma treated with DA-EPOCH-R2. Additional objectives include evaluating lenalidomide's pharmacokinetics and HIV latency reversal as well as response rates, progression-free and event free survivals for those receiving EPOCH-R therapy."

Answered by AI

How many participants are receiving care in this research project?

"Affirmative. According to information on clinicaltrials.gov, this experiment is actively recruiting participants with the first posting date being July 3rd 2017 and the last update taking place October 15th 2022. The trial requires 36 people in total between 1 medical centre."

Answered by AI

Is there availability for participants in this research program?

"Confirmed. Clinicaltrials.gov records demonstrate that this medical trial, which was initially posted on July 3rd 2017, is still looking for participants. A total of 36 patients are desired from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma

2017. "Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02911142.

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