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New treatment option for Diffuse Large Cell Lymphoma
Official title Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
ClinicalTrials.gov ID: NCT05389423
What this study is testing
What is Vincristine?
Vincristine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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 how well it works assessment of the investigational regimen per Protocol Chair...
- 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...
- 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...
- Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.