| Eligibility |
- INCLUSION CRITERIA:
- 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
- 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 participants <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. The use
of rituximab for the treatment of KSHV-associated MCD or KICS or the use of steroids
are allowed within 2 weeks prior to start of treatment.
- Phase I or Phase II participants who have received prior dose-adjusted EPOCH for
treatment for PEL or KSHV-associated large cell lymphoma
- Phase II participants who have received any prior curative-intent therapy for PEL or
KSHV-associated large cell lymphoma. Participants 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 participants with Gilbert's
syndrome as defined by >80% unconjugated
- Total bilirubin greater than or equal to 7.5 with direct fraction > 0.7 if
participants 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. Participants 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.
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