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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
Must not have
Inadequate renal function, defined as calculated or estimated creatinine clearance < 60 mL/min unless lymphoma, KSHV-MCD, or KICS- related for calculation of creatinine clearance)
CTCAEv5.0 Grade 3-4 neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post end of treatment
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low, with a creatinine clearance under 60 mL/min.
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I have severe nerve pain or damage.
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I am not pregnant, as the medication used in this study could harm an unborn baby.
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I am not breastfeeding or agree to stop while on lenalidomide.
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My lymphoma has spread to the brain.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(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 study objectives
HIV
lenalidomide PK
response rates and progression-free survival
+1 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: 1Experimental Treatment7 Interventions
Lenalidomide, Rituximab, Prednisone, Etopiside, Doxorubicin, Vincristine and Cyclophosphamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Rituximab
1999
Completed Phase 4
~2990
Prednisone
2014
Completed Phase 4
~2500
Doxorubicin
2012
Completed Phase 3
~8030
Vincristine
2003
Completed Phase 4
~2970
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,158 Total Patients Enrolled
Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
112 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
~1 spots leftby Dec 2025
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