Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 877 for:    "Reticulum Cell Sarcoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02911142
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

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.

Objective:

To test a new treatment for PEL.

Eligibility:

People ages 18 and older with PEL.

Design:

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:

Blood tests

Scans

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:

Medical history

Physical exam

Blood, urine, and stool tests

Lesions photographed and measured

Lumbar puncture

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 Lymphoma Drug: Lenalidomide Drug: Rituximab Drug: Prednisone Drug: Etopside Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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, 2022
Estimated Study Completion Date : October 1, 2025


Arm Intervention/treatment
Experimental: 1
Patients with PEL and KSHV-associated large cell lymphoma
Drug: Lenalidomide
Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.

Drug: Rituximab
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.

Drug: Prednisone
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.

Drug: Etopside
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.

Drug: Doxorubicin
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.

Drug: Vincristine
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.

Drug: Cyclophosphamide
During cycle 1, Cyclophosphamide 750 mg/m2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m2 day 5.




Primary Outcome Measures :
  1. (Phase I) Maximum tolerated dose of DA-EPOCH_R2 [ Time Frame: One year ]
    Association of treatment regimen with one-year overall survival

  2. (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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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.
  • 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
  • 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.
  • Able to take aspirin 81mg orally daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin.
  • Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

  • Use of other systemic anticancer treatments or agents within the past 2 weeks (4 weeks if the therapy was a monoclonal antibody)
  • Phase I or Phase II patients who have prior dose-adjusted EPOCH for treatment for PEL or KSHV-associated large cell lymphoma
  • Phase II patients who have received any prior curative-intent therapy for PEL or KSHV-associated large cell lymphoma. Patients who have received prior treatment as a bridge to curative-intent therapy will be considered per PI discretion.
  • Parenchymal brain involvement with lymphoma
  • History of malignant tumors other than KS or KSHV-associated MCD, unless:

    • In complete remission for greater than or equal to 1 year from the time response was first documented or
    • Completely resected basal cell carcinoma or
    • In situ squamous cell carcinoma of the cervix or anus
  • 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)
  • Inadequate hepatic function
  • Bilirubin (total) > 1.5 times the upper limit of normal; AST and/or ALT > 3 times the upper limit of normal; EXCEPTIONS:

    • Total bilirubin greater than or equal to 5 mg/dL in patients with Gilbert's syndrome as defined by >80% unconjugated
    • Total bilirubin greater than or equal to 7.5 with direct fraction > 0.7 if patient is receiving a protease inhibitor at the time of initial evaluation
    • Hepatic dysfunction attributed to lymphoma, KSHV-MCD, or KICS
  • ANC <1000/mm3 and platelets < 75,000/mm3 unless lymphoma, KSHV-MCD, or KICS- related.
  • CTCAEv5.0 Grade 3-4 neuropathy
  • Ejection fraction less than 40% by echocardiography
  • Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
  • History of hypersensitivity reactions attributed to thalidomide, lenalidomide, or pomalidomide, including prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, or pomalidomide.
  • Breast feeding (if lactating, must agree not to breast feed while taking lenalidomide). Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide.
  • Uncontrolled severe intercurrent illness including, but not limited to: bacterial, fungal, or life-threatening viral infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements. Patients with severe intercurrent illnesses attributed to lymphoma, KSHV-MCD, or KICS may be eligible per PI s or designee s discretion.
  • Any condition, including laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
  • Pregnant women are excluded from this study because lenalidomide is a Category X agent with the potential for teratogenic or abortifacient effects. These potential risks may also apply to other agents used in this study.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anaida Widell (301) 451-3694 awidell@cc.nih.gov

Locations
Layout table for location information
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      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Kathryn A Lurain, M.D. National Cancer Institute (NCI)

Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02911142     History of Changes
Other Study ID Numbers: 160171
16-C-0171
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 11, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Treatment Naive
Immune Modulatory
Chemotherapy
AIDS-Related Lymphoma
PEL

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Primary Effusion
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Prednisone
Lenalidomide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors