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:

• Adults aged 18 or older
• People who have been diagnosed with a specific type of blood cancer called diffuse large B-cell lymphoma (DLBCL), confirmed by a tissue test — including a related form involving MYC and BCL2 gene changes
• People who have not yet received any treatment for their lymphoma
• People who are willing and able to attend clinic visits and follow the study procedures
• People who are reasonably well and able to carry out daily activities (based on a standard health scoring system rated 0–2, where 0 is fully active and 2 means limited in physically demanding work but able to care for oneself)
• People with a life expectancy of at least 3 months
• People whose lymphoma is at a more advanced or widespread stage (Stage II–IV on a standard staging scale)
• People whose lymphoma scores at least 2 on a standard risk-scoring tool used by doctors
• People whose lymphoma has at least one measurable area visible on CT and PET scans
• People whose heart is pumping at least 45% efficiency, confirmed by a heart scan
• People who are able to swallow tablets without difficulty
• People who agree to use contraception or abstain from sex during treatment and for 10 months after the last dose (for women) or 7 months (for men)
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study drug
• People whose blood test results meet specific minimum levels for kidney function, liver function, blood cell counts, and other markers (the trial site will check these)

Who may not be able to join:

• People with a known allergy or intolerance to the study drug roflumilast
• People with a known allergy or intolerance to the other study drug, loncastuximab
• People who currently have another active cancer other than DLBCL
• People who are currently taking part in another interventional clinical trial
• People who have had a donor bone marrow transplant within the past 12 months
• People who have had their own stem cell transplant within the past 6 months
• People who have received cancer treatments — including immunotherapy, chemotherapy, radiotherapy, or experimental therapy — within the past 6 months
• People whose lymphoma has spread to the brain or spinal fluid and is currently active
• People with an active infection that is not under control
• People with poorly managed depression or depressive symptoms
• People with serious medical conditions that would make participation too risky, such as a heart attack in the past 6 months, unstable chest pain, uncontrolled diabetes, or severe heart failure
• People with a history of another cancer, unless it was a minor skin cancer that has been treated, early-stage prostate cancer, or another cancer with no signs of return for at least 1 year and no ongoing cancer treatment
• People who have had major surgery within the past 3 weeks or minor surgery within the past 1 week before starting the study drug
• People with other medical or mental health conditions that, in the doctor's judgement, could affect their safety or the reliability of the study results
• People with a specific type of abnormal heart rhythm reading on an ECG (confirm with trial site)
• People with elevated levels of a heart-stress marker (troponin) in their blood at the start of the study
• People with an elevated level of another heart-stress marker (BNP) in their blood at the start of the study
• People with an elevated level of a digestive enzyme (amylase) in their blood at the start of the study
• People who are HIV-positive with drug-resistant HIV, very low immune cell counts, or other HIV-related complications
• People who test positive for active Hepatitis B or Hepatitis C, unless liver function tests are near normal and there is no history of chronic active hepatitis
• People with moderate or severe liver disease
• People who are pregnant or breastfeeding
• People currently taking certain specific medications that could interact with the study drug — including but not limited to carbamazepine, rifampin, ketoconazole, itraconazole, fluvoxamine, ciprofloxacin, St. John's Wort, and several others (confirm the full list with the trial site)
• People currently taking certain HIV medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs), including efavirenz, rilpivirine, nevirapine, and others in this drug class

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