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:

• Adults aged 18 years or older who have given their written consent to participate.
• People whose ability to carry out daily activities is not severely limited (based on a standard medical scale called ECOG, with a score of 2 or lower).
• People who have been diagnosed — through a tissue biopsy — with one of the following specific types of T-cell lymphoma: angioimmunoblastic T-cell lymphoma (AITL), nodal peripheral T-cell lymphoma with a TFH pattern, or follicular T-cell lymphoma (FTCL).
• People who have completed their first course of chemotherapy using a CHOP-based drug combination, and whose scans show a complete response (cancer no longer detectable) within the past 6 months before joining the trial.
• People who are not suitable for, or who have chosen not to have, a stem cell transplant using their own cells — either because a doctor has assessed them as medically unfit, or because they are aged 65 or older, or because they are aged 18 or older with a transplant-specific health score of 3 or higher (confirm with trial site).
• People whose side effects from previous treatment have mostly resolved, with only mild symptoms remaining (nerve-related side effects up to a moderate level, and hair loss, are exceptions).
• People whose blood test results fall within the required ranges, including: platelets at or above 25,000/mm³; haemoglobin at or above 8 g/dL; and a specific immune cell count (CD4) at or above 50/mm³.
• People whose liver function tests are within acceptable limits (confirm with trial site if a condition called Gilbert's Syndrome applies).
• People whose kidney function tests are within acceptable limits.
• People who test negative for HIV, active hepatitis B, and active hepatitis C — or who have specific hepatitis B results that meet defined criteria and are willing to have regular monitoring (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test within 1 week before starting treatment.
• People of reproductive potential who are willing to use a highly effective form of contraception throughout the trial and for at least 1 month after the last dose of the study drug (duvelisib).

Who may not be able to join:

• People who have previously received an organ transplant.
• People who have had major surgery within 4 weeks before joining the trial.
• People who have received a live vaccine within 30 days before the trial start date.
• People who are unable to take preventive medication for a lung infection called pneumocystis pneumonia.
• People currently taking certain medications or foods that strongly interact with a liver enzyme called CYP3A — these must be stopped at least 2 weeks before starting the study drug.
• People whose lymphoma has spread to the brain or spinal cord.
• People with an active cytomegalovirus (CMV) infection (a type of viral infection detectable in blood tests).
• People who have been treated for tuberculosis within the past 2 years.
• People with a current active infection (bacterial, viral, fungal, or other) that requires systemic treatment — treatment for the infection must be completed before the trial begins.
• People with signs or symptoms of COVID-19 who have not met specific testing requirements showing they are no longer infectious (confirm with trial site).
• People with a history of liver cirrhosis or long-term heavy alcohol use.
• People with significant bowel or digestive conditions — such as Crohn's disease, ulcerative colitis, coeliac disease, or prior stomach surgery — that could affect how the study drug is absorbed by the body.
• People with another active cancer that could interfere with the trial, unless specifically approved by the lead investigator (note: certain non-invasive skin cancers and early cervical changes may be permitted without special approval).
• People with significant uncontrolled health conditions, such as serious lung disease, uncontrolled diabetes, severe psychiatric conditions, or unstable heart conditions — including a heart attack, stroke, or unstable chest pain in the past 6 months; moderate-to-severe heart failure; uncontrolled irregular heartbeat; or uncontrolled high blood pressure.
• People with certain abnormal heart rhythm findings on an ECG (heart tracing) that the investigating doctor considers clinically significant.
• People with a known allergy to duvelisib or to drugs with a similar chemical make-up.
• People who are currently participating in another clinical trial involving an experimental treatment.
• Women who are currently breastfeeding.
• People who, in the investigator's judgement, have any other condition that makes participation unsafe.
• People who, in the investigator's opinion, may not be able to follow all the requirements of the trial.

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