Combining Pomalidomide with Chemotherapy for HIV-Related Lymphomas
Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
This study is testing if adding a drug called pomalidomide to chemotherapy can help adults with HIV-related lymphomas feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05389423 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of pomalidomide in combination with a chemotherapy regimen known as dose-adjusted EPOCH, with or without rituximab, in treating adults diagnosed with HIV-associated B-cell non-Hodgkin lymphoma (NHL). Participants will undergo a series of screenings, including physical exams, blood tests, and imaging scans, to assess their eligibility and health status. The treatment will consist of up to six cycles, with the first cycle lasting 26 days, during which pomalidomide will be administered alongside other chemotherapy agents. The study seeks to address the unique challenges faced by individuals with both HIV and NHL, as their disease may differ from that of the general population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with HIV-associated B-cell non-Hodgkin lymphoma and exhibit high-risk features.
Not a fit: Patients who have previously received curative-intent chemotherapy for lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with HIV-associated lymphomas, potentially improving their survival rates.
How similar studies have performed: While there have been studies exploring treatments for HIV-associated lymphomas, the specific combination of pomalidomide with dose-adjusted EPOCH is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), 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 * Gamma herpesvirus positive tumor * Presence of KS * Measurable or evaluable lymphoma. * Positive HIV1/2 serology. * 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. * Age \>=18 years * Eastern Cooperative Oncology Group performance status (ECOG-PS) \<=4 * 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. * 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. * 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. * Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis. * 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 (individuals with history of Gilbert disease are eligible if total bilirubin \<= 5 mg/dL with \<80% unconjugated bilirubin) * aspartate aminotransferase (AST) / alanine transaminase (ALT) \<=3 X institutional upper limit of normal * creatinine clearance \>=60 mL/min/1.73 m\^2 for individuals with creatinine levels above institutional normal. * Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy. * Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART). * Individuals must understand and sign a written informed consent document. EXCLUSION CRITERIA: * Individuals may not receive investigational agents on other clinical trials. * Requirement of 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 KS or KSHV-associated multicentric Castleman Disease, (MCD), 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, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment. * 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 nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ramya M Ramaswami, M.D. — National Cancer Institute (NCI)
- Study coordinator: Anaida Widell
- Email: anaida.widell@nih.gov
- Phone: (240) 760-6074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.