Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

This is an interventional treatment trial for Diffuse Large Cell Lymphoma focused on measuring Non-Hodgkin Lymphoma, Epstein Barr Virus, Plasmablastic Lymphoma, Chemotherapy, Immune Modulatory Read More

• INCLUSION CRITERIA:

• Participants must have histologically or cytologically confirmed B-cell non-Hodgkin lymphoma confirmed by the Laboratory of Pathology, NCI, with one or more of the following features:

  • Leptomeningeal/CSF involvement
  • High-risk for CNS relapse per CNS-IPI (score 4-6)
  • Plasmablastic histology
  • Gammaherpesvirus positive tumor
  • Presence of Kaposi sarcoma
• Measurable or evaluable lymphoma.
• Positive HIV1/2 serology.
• Participants may not have received prior curative-intent chemotherapy for lymphoma.
• Participants who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration.
• Age >=18 years
• ECOG performance status <=4
• Persons of childbearing potential (PCBP) 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 pomalidomide and must either commit to continued abstinence from penetrative vaginal 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 the participant starts taking pomalidomide and for 28 days after the last dose of pomalidomide.
• All study participants must agree to be registered into the mandatory POMALYST REMS[Registered]TM program and be willing and able to comply with the requirements of the POMALYST REMS[Registered]TM program.
• Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.

• Participants must have adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:

  • absolute neutrophil count >=1,000/mcL
  • platelets >=75,000/mcL
  • total bilirubin <=1.5 X institutional upper limit of normal (participants with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin)
  • AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal
  • creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
• Participants with hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.
• Participants must be willing to take and adhere to antiretroviral therapy (participants are not required to be on any specific regimen of antiretroviral therapy).
• Participants must understand and sign a written informed consent document.

EXCLUSION CRITERIA:

• Participants who are receiving any other investigational agents.
• Participants requiring any of the agents listed as prohibited thearapies.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
• Parenchymal brain involvement with lymphoma.
• Ejection fraction less than 40% by echocardiography (ECHO)
• CTCAEv5.0 Grade 3-4 neuropathy

• History of malignant tumors other than Kaposi sarcoma or KSHV-associated multicentric Castleman Disease, unless:

  • In complete remission for >= 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; or,
  • Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.
• 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.
• Symptomatic congestive heart failure
• Unstable angina pectoris, or cardiac arrhythmia.
• Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.
• Pregnant or breast-feeding persons (if lactating, must agree not to breast feed while taking pomalidomide).