Phase 2 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 diagnosed with one of the following types of aggressive blood cancer: double-expressor lymphoma (DEL), high-grade B-cell lymphoma with certain gene changes (MYC and BCL2 and/or BCL6 rearrangements), or Burkitt lymphoma — who have already received at least two prior treatments (or at least one prior treatment for Burkitt lymphoma), and for whom no standard treatment options remain effective
• Adults aged 18 or older
• People who are well enough to carry out basic daily activities, as measured by a standard health scoring system (ECOG score of 2 or lower, or a score of 3 if the reduced function is directly caused by the lymphoma, as determined by the treating doctor)
• People whose blood counts meet minimum levels — specifically, a neutrophil count of at least 1,000/mcL and a platelet count of at least 50,000/mcL (confirm with trial site)
• People whose liver function blood test results fall within acceptable ranges set by the trial
• People with a specific liver condition called Gilbert's syndrome may still be considered, provided certain liver test results meet the trial's requirements (confirm with trial site)
• People whose kidneys are functioning at an adequate level, based on a calculated filtration rate of at least 60 mL/min (confirm with trial site)
• People living with HIV, provided they are on effective treatment and have had an undetectable viral load within the past 6 months
• People with a history of hepatitis B, provided the virus is undetectable while on appropriate treatment
• People with a history of hepatitis C who have been fully treated and cured, or who are currently on treatment with an undetectable viral load
• People who have or have had another cancer, provided that cancer and its treatment are not expected to interfere with this trial's assessments (as determined by the trial site)
• People with a history of heart disease or prior treatment with heart-affecting therapies, provided a clinical assessment places their heart function at Class II or better using a standard heart health scale
• People with low blood counts caused by bone marrow involvement from lymphoma, or following CAR T-cell therapy, may be considered if the treating doctor determines participation is safe
• People with no signs of lymphoma affecting the brain or spinal cord
• People who are willing to use effective contraception starting 14 days before the trial, throughout participation, and for at least 6 months after the last dose — this applies to both women who could become pregnant and men; women should not breastfeed during treatment and for 6 months after; egg and sperm donation should not occur during participation or for 6 months after the last dose
• People willing to provide blood and tissue biopsy samples for research
• People who are able to understand the trial and are willing to sign a written consent form

Who may not be able to join:

• People who have not yet recovered from significant side effects of their most recent cancer treatment (side effects must have reduced to a mild level or resolved, with the exception of hair loss or low lymphocyte counts)
• People taking certain medications that strongly affect a liver enzyme called CYP3A4 — either strong inhibitors or strong inducers of this enzyme — as these may interact with the trial drug (confirm with trial site if uncertain about specific medications)
• People whose heart's electrical activity shows a prolonged interval on an ECG (a QTc interval greater than 480 milliseconds)
• People currently participating in another clinical trial involving an experimental treatment
• People with a history of serious allergic reactions to substances chemically similar to the trial drug CX-5461 (Pidnarulex)
• People with serious uncontrolled illness or other significant health conditions that would make trial participation unsafe
• People who are pregnant, as the trial drug may harm a developing baby
• People who are breastfeeding, as the potential risk to a nursing infant is unknown

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