Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a type of blood cancer called B-cell non-Hodgkin lymphoma (NHL), confirmed by tissue or cell testing, and whose cancer has one or more of these features: cancer cells found in the fluid around the brain or spine; a high risk of the cancer spreading to the brain (based on a scoring tool called CNS-IPI, with a score of 4–6); a specific cancer type called plasmablastic lymphoma; a tumour linked to a type of herpesvirus (gamma herpesvirus); or a condition called Kaposi sarcoma (KS)
• People whose lymphoma can be measured or tracked on scans or tests
• People who have tested positive for HIV (type 1 or 2)
• People who have not previously received chemotherapy intended to cure their lymphoma (those who had earlier treatment as a "bridge" to curative treatment may be considered by the trial team if at least 2 weeks have passed since that treatment)
• People aged 18 or older
• People whose general health and ability to function falls within a certain range on a standard medical scale (ECOG performance status of 4 or below, which includes a wide range of health levels — confirm with trial site)
• People who could become pregnant must have a negative pregnancy test before starting the study, and must agree to use two forms of birth control simultaneously (one highly effective, one additional) for at least 28 days before starting one of the study drugs (pomalidomide) and for 12 months after the last dose of chemotherapy
• People who are able to father a child must agree to use an effective form of contraception throughout treatment and for 6 months after the last study drug dose, and must not freeze or donate sperm during this period
• People who are willing and able to enrol in a required safety monitoring programme called POMALYST REMS (a programme specific to one of the study drugs)
• People who are able to take a low-dose aspirin (81mg) daily, or a suitable alternative to help prevent blood clots
• People whose blood counts and organ function meet minimum levels set by the trial (unless any abnormalities are caused by the lymphoma or HIV), including: adequate white blood cell levels, platelet counts, liver function, and kidney function
• People with hepatitis B virus (HBV) infection who are already on antiviral treatment to keep the virus suppressed
• People who are willing to take and stick to HIV antiretroviral therapy (ART) — no specific ART regimen is required
• People who are able to understand and sign a written consent form

Who may not be able to join:

• People who are currently taking part in another clinical trial involving experimental treatments
• People who require any medications listed as prohibited in the trial protocol (confirm with trial site for the specific list)
• People who have had a serious allergic reaction to pomalidomide or to drugs with a similar chemical or biological makeup to the drugs used in this trial
• People whose lymphoma has spread into the brain tissue itself (as opposed to the fluid surrounding the brain or spine)
• People whose heart pumping function is below 40%, as measured by a heart ultrasound (echocardiogram)
• People with severe nerve damage (rated Grade 3 or 4 on a standard medical scale)
• People who have had another type of cancer — other than KS or a related condition called KSHV-associated multicentric Castleman disease — unless: the cancer has been in complete remission for at least 1 year; it was a completely removed basal cell skin cancer; it was a very early-stage (in situ) skin or cervical/anal cancer; or the trial chair determines it is unlikely to affect the safety or results of this trial
• People with certain known blood-clotting disorders, including specific inherited or drug-related conditions affecting the blood's ability to clot properly (confirm with trial site for the full list of affected conditions)
• People with symptomatic heart failure
• People with unstable chest pain (angina), or certain types of irregular heartbeat that are causing symptoms or requiring medical treatment
• People with a serious, uncontrolled medical condition, illness, or active infection (other than lymphoma or HIV) that is not well managed
• People who are pregnant or breastfeeding (those who are breastfeeding must agree not to do so while taking pomalidomide)

Important: Always verify eligibility with the trial site directly before applying.