Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02911142|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : December 24, 2020
Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers want to see if a drug called lenalidomide along with common chemotherapy drugs may be effective in treating PEL.
To test a new treatment for PEL.
People ages 18 and older with PEL.
Participants will be screened with blood tests, imaging studies, a physical exam, and other tests.
Participants will have tests to evaluate their disease. These may include:
Lumbar puncture. Fluid around the spinal cord will be removed with a needle.
Bone marrow removed with a needle and studied
Samples of skin or lymph nodes removed
Fluid removed from around organs
Lung and eye tests
Tubes with cameras taking pictures of airways or digestive tract
Participants will take lenalidomide pills for 10 days. They will keep a pill diary.
Participants will have a catheter (small tube) placed in the large vein in the arm or chest.
Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This will be repeated in 21-day cycles. Most participants will have 6 cycles.
Participants will get the drug filgrastim by injection under the skin. They will get the drug methotrexate injected into the spinal fluid.
During the study, participants will have the following tests done at least once:
Blood, urine, and stool tests
Lesions photographed and measured
Participants will have follow-up visits for 5 years. They will repeat the screening tests plus have urine and stool tested.
Participants may be contacted later by phone to see how they are doing.
|Condition or disease||Intervention/treatment||Phase|
|Primary Effusion Lymphoma B-Cell Neoplasm||Drug: Lenalidomide Drug: Rituximab Drug: Prednisone Drug: Etopside Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R(2)) In Primary Effusion Lymphoma or KSHV-Associated Large Cell Lymphoma|
|Actual Study Start Date :||July 3, 2017|
|Estimated Primary Completion Date :||October 1, 2023|
|Estimated Study Completion Date :||October 1, 2027|
Lenalidomide, Rituximab, Prednisone, Etopiside, Doxorubicin, Vincristine and Cyclophosphamide
Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.
During cycle 1, rituximab will be administered on day 4 prior to the start of EPOCH. During cycles 2 to 6, rituximab will be administered on day 1 of each cycle.
During cycle 1, Prednisone 60 mg/m2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m2 /day PO days 1-5.
During cycle 1, Etoposide 50 mg/m2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide 50 mg/m2/day continuous intravenous infusion days 1 to 4.
During cycle 1, Doxorubicin 10 mg /m2/day continuous intravenous infusion days 6 to 9. During cycles 2-6, Doxorubicin continuous intravenous infusion days 1 to 4.
During cycle 1, Vincristine 0.4 mg/m2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Vincristine continuous intravenous infusion days 1 to 4.
During cycle 1, Cyclophosphamide 750 mg/m2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m2 day 5.
- (Phase I) Maximum tolerated dose of DA-EPOCH_R2 [ Time Frame: One year ]Association of treatment regimen with one-year overall survival
- (Phase II) Overall survival in treatment-naive patients with primary effusion lymphoma treated with DA-EPOCH-R2 [ Time Frame: One year post end of treatment ]Median amount of time subject survives post therapy
- response rates and progression-free survival [ Time Frame: from start of treatment to time of progression of KSHV-lymphoma or death, whichever occurs first ]Evaluate response rates and progression-free survival, and event-free survival for primary effusion lymphoma treated with DA-EPOCH-R2
- lenalidomide PK [ Time Frame: C1D1, C1D7, C6D1 ]Evaluate pharmacokinetics of lenalidomide in blood, effusion and CSF
- HIV latency reversal [ Time Frame: C1D1, C1D2, C1D6, EOT, follow-up ]In HIV infected patients, evaluate the effect of lenalidomide alone and in combination with EPOCH-R on HIV latency reversal and cellular measures of HIV
- tenofovir and tenofovirdiphosphate PK [ Time Frame: C1D1, C1D7, C6D1 ]Evaluate the pharmacokinetics of tenofovir and tenofovir-diphosphate in plasma and PBMCs, respectively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911142
|Contact: Anaida Widell||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Kathryn A Lurain, M.D.||National Cancer Institute (NCI)|