RECRUITING

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

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Conditions

Diffuse Large Cell LymphomaNon-Hodgkin LymphomaBurkitt LymphomaPlasmablastic LymphomaB-Cell NeoplasmEpstein Barr VirusChemotherapyImmune Modulatory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating people with both HIV and NHL. Objective: To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL. Eligibility: Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features. Design: Individuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed. Individuals will receive up to 6 cycles of treatment. The first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete. The remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle. Screening tests will be repeated at study visits. Follow-up visits will continue for 4 years....

Official Title

Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

Quick Facts

Study Start:2023-06-27
Study Completion:2032-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05389423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:
  2. * Leptomeningeal/CSF involvement
  3. * High-risk for CNS relapse per CNS-IPI (score 4-6)
  4. * Plasmablastic histology
  5. * Gamma herpesvirus positive tumor
  6. * Presence of KS
  7. * Measurable or evaluable lymphoma.
  8. * Positive HIV1/2 serology.
  9. * Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if \>= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.
  10. * Age \>=18 years
  11. * Eastern Cooperative Oncology Group performance status (ECOG-PS) \<=4
  12. * Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 2 weeks prior to and again within 1 day before starting the study drugs 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 12 months after the last dose of combined chemotherapy.
  13. * Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.
  14. * All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.
  15. * Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.
  16. * Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:
  17. * absolute neutrophil count \>=1,000/mcL
  18. * platelets \>=75,000/mcL
  19. * total bilirubin \<=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin \<= 5 mg/dL with \<80% unconjugated bilirubin)
  20. * aspartate aminotransferase (AST) / alanine transaminase (ALT) \<=3 X institutional upper limit of normal
  21. * creatinine clearance \>=60 mL/min/1.73 m\^2 for individuals with creatinine levels above institutional normal.
  22. * Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.
  23. * Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).
  24. * Individuals must understand and sign a written informed consent document.
  1. * Individuals may not receive investigational agents on other clinical trials.
  2. * Requirement of any of the agents listed as prohibited thearapies.
  3. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
  4. * Parenchymal brain involvement with lymphoma.
  5. * Ejection fraction less than 40% by echocardiography (ECHO)
  6. * CTCAEv5.0 Grade 3-4 neuropathy
  7. * History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:
  8. * In complete remission for \>= 1 year from the time response was first documented; or,
  9. * Completely resected basal cell carcinoma; or,
  10. * In situ squamous cell carcinoma of the cervix or anus; or,
  11. * 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.
  12. * 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.
  13. * Symptomatic congestive heart failure
  14. * Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.
  15. * 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.
  16. * Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).

Contacts and Locations

Study Contact

Anaida Widell
CONTACT
(240) 760-6074
anaida.widell@nih.gov
Kathryn A Lurain, M.D.
CONTACT
(301) 250-5156
kathryn.lurain@nih.gov

Principal Investigator

Kathryn A Lurain, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Kathryn A Lurain, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2032-06-01

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2032-06-01

Terms related to this study

Keywords Provided by Researchers

  • Non-Hodgkin Lymphoma
  • Epstein Barr Virus
  • Plasmablastic Lymphoma
  • Chemotherapy
  • Immune Modulatory

Additional Relevant MeSH Terms

  • Diffuse Large Cell Lymphoma
  • Non-Hodgkin Lymphoma
  • Burkitt Lymphoma
  • Plasmablastic Lymphoma
  • B-Cell Neoplasm