Vincristine for Lymphoma, Primary Effusion

1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Lymphoma, Primary Effusion+4 More
Vincristine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, Primary Effusion

Study Summary

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

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Eligible Conditions

  • Lymphoma, Primary Effusion
  • Lymphoma, B-Cell
  • Lymphoma
  • Primary Effusion Lymphomas
  • B-Cell Neoplasm

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Vincristine will improve 2 primary outcomes and 4 secondary outcomes in patients with Lymphoma, Primary Effusion. Measurement will happen over the course of C1D1, C1D2, C1D6, EOT, follow-up.

C1D1, C1D2, C1D6, EOT, follow-up
HIV latency reversal
C1D1, C1D7, C6D1
lenalidomide PK
tenofovir and tenofovirdiphosphate PK
One year
(Phase I) Maximum tolerated dose of DA-EPOCH_R2
One year post end of treatment
(Phase II) Overall survival in treatment-naive patients with primary effusion lymphoma treated with DA-EPOCH-R2
from start of treatment to time of progression of KSHV-lymphoma or death, whichever occurs first
response rates and progression-free survival

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
1

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. Vincristine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

1Lenalidomide, Rituximab, Prednisone, Etopiside, Doxorubicin, Vincristine and Cyclophosphamide
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Prednisone
FDA approved
Lenalidomide
FDA approved
Rituximab
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year post end of treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year post end of treatment for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphoma, Primary Effusion or one of the other 4 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All study participants must agree to be registered into the mandatory REVLIMID REMS program, and be willing and able to comply with the requirements of the REVLIMID REMS program.
Ability of subject to understand and the willingness to sign a written informed consent document.
Any HIV status
Age 18 years or greater. Because no dosing or adverse event data are currently available on the use of lenalidomide in combination with EPOCH-R in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
ECOG performance status 0-4.
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 1 day before starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control
Able to take aspirin 81mg orally daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin.
Primary effusion lymphoma (PEL), including extracavitary variant, and KSHVassociated large cell lymphoma that is pathologically confirmed by the NCI Laboratory of Pathology
Measurable or assessable lymphoma.

Patient Q&A Section

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

What is lymphoma, primary effusion?

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About 45% of patients with lymphoma, primary effusion, develop CNS involvement during their treatment. When CNS involvement occurs, it is usually a progressive, fatal, and treatment-refractory illness, with death occurring within one month of onset. The majority of patients were women. Survival is poorer among patients with CNS involvement.

Unverified Answer

Can lymphoma, primary effusion be cured?

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For lymphomas with very limited, bulky disease, curative treatment may be possible. PEG-IFN plus rituximab remains active against PEL. However, in lymphomas with extensive bulky disease, with an extended disease-free interval, and in patients undergoing intensive chemotherapy, cure rates are exceedingly low. PEG-IFN and rituximab and chemotherapy, regardless of the initial regimen, appear to be ineffective in controlling disease progression.

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How many people get lymphoma, primary effusion a year in the United States?

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This is the largest epidemiologic study to date. The total number of cases of lymphoma, PEA in the United States is 1.5 times higher than previously documented in the literature, while the proportion of cases diagnosed in the elderly is twofold higher. Data from a recent study indicate that the numbers of patients diagnosed with PEA and lymphomas are increasing.

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What causes lymphoma, primary effusion?

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The risk of developing primary effusion lymphoma is increased in untreated patients with HIV and HIV-related immunodeficiency. The risk of developing other types of lymphoma is also increased. Patients should be carefully examined to find evidence of previous and comorbid lymphoproliferative disorders and be monitored during therapy for opportunistic infections and malignancies to detect other lymphomas.

Unverified Answer

What are common treatments for lymphoma, primary effusion?

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Lymphoma and PEL are both serious cancers, but the outcome for PEL patients was more favorable. For PEL patients, there are currently no known common treatments. At this time, doctors have to decide how to treat PEL patients and choose the right medicine based on their patients' symptoms and physical evaluation. In addition, doctors should have a plan in case of complications, which is probably very common. Treatment options should be reconsidered once more evidence becomes available.

Unverified Answer

What are the signs of lymphoma, primary effusion?

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Some of the main signs of lymphoma, primary effusion, include fever, night sweats, weight loss, and pain in the extremities. Other key signs of lymphoma, primary effusion, include erythema nodosum, B symptom, swollen lymph nodes, and the presence of pleural effusions.

Unverified Answer

How does lenalidomide work?

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Lenalidomide is a more potent T-lymphocyte stimulator, compared with thalidomide. The mechanism of action includes downregulating Interleukin 2 expression by T cells and induction of apoptosis in T cells.

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Have there been other clinical trials involving lenalidomide?

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To our knowledge there is no other randomized trial-level evidence on efficacy of lenalidomide in patients with primary effusions. Therefore, the evidence base for the efficacy of lenalidomide is limited. More data on the long-term efficacy of lenalidomide are needed; studies on efficacy and safety of lenalidomide as part of combination therapies for PCML warrant investigation, especially since lenalidomide and paclitaxel plus etoposide/dexamethasone/bortezomib is currently the first line therapy for patients with B-cell non-Hodgkin lymphoma in the UK and France.

Unverified Answer

How quickly does lymphoma, primary effusion spread?

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The study revealed that the disease rapidly disseminates. A patient with a diagnosis of DLBCC should be monitored in a specialist department after the last day of therapy.

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Does lenalidomide improve quality of life for those with lymphoma, primary effusion?

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Lenalidomide and standard therapy improve quality of life in patients with lymphoma, PEL, in addition to an improvement in response rate and PEL progression free rate.

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What are the common side effects of lenalidomide?

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These include nausea or vomiting, diarrhea, fatigue, pain, weakness, loss of appetite, and skin reactions such as hives and flushing. Lenalidomide can induce a very high level of white blood cell counts and neutropenia. Regular surveillance and monitoring of blood counts are recommended during therapy. This drug may interfere with the use of other medications or supplements that may affect the blood counts.

Unverified Answer

What is the latest research for lymphoma, primary effusion?

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A recent study found that patients with a history of lymphoma have an increased incidence of PE. PE is a common cause of unexplained fever and unexplained weight loss in patients with unexplained or unexplained lymphadenopathy. Physicians may consider biopsies in patients with unexplained fevers and unexplained weight loss.

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