Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the 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 an aggressive type of B-cell lymphoma (specifically certain subtypes of diffuse large B-cell lymphoma or high-grade B-cell lymphoma), confirmed by a specific laboratory at the NCI, who have not yet received any treatment for this diagnosis.
• People whose diagnosis falls into one of these specific subtypes: ABC-type DLBCL, GCB-type DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary cutaneous DLBCL leg-type, EBV-positive DLBCL, DLBCL associated with chronic inflammation, ALK-positive large B-cell lymphoma, high-grade B-cell lymphoma NOS, or high-grade B-cell lymphoma with certain specific genetic changes (MYC and BCL2 and/or BCL6 rearrangements).
• People who also have a slower-growing type of lymphoma alongside their diagnosis (such as follicular lymphoma or certain others) may still be considered eligible (confirm with trial site).
• People for whom a stored or freshly collected tumour tissue sample is available, or who are willing to have a biopsy taken if no adequate stored sample exists.
• People who have measurable lymph node(s) or tumour mass(es) of at least 1.5 centimetres, as seen on a CT or MRI scan.
• People whose lymphoma is classified as Stage II, III, or IV under a standard staging system called the Ann Arbor Classification.
• People aged 18 years or older.
• People who are reasonably physically functional, as measured by a standard scale used in cancer care (ECOG performance status of 0, 1, or 2 — meaning able to care for oneself, even if not able to do heavy physical work).
• People whose blood counts and organ function (including liver and kidney) meet certain minimum levels, as determined by blood tests — with some flexibility if the lymphoma itself is causing these values to be lower than normal.
• People of any HIV status, provided their HIV status is confirmed before joining.
• People who are able to understand the study and are willing to sign a consent form agreeing to participate.
• People who are able to become pregnant must have a negative pregnancy test within 7 days before enrolling, and must agree to use highly effective contraception during the study and for a set period after treatment ends.
• People who are able to father children must agree to use highly effective contraception during the study and for 12 months after completing chemotherapy.
• Participants must not be planning to conceive or father children during the trial period or for a specified time after treatment ends.

Who may not be able to join:

• People whose lymphoma is one of the following specific subtypes: primary DLBCL of the brain or central nervous system (PCNSL), primary mediastinal B-cell lymphoma (PMBL), plasmablastic lymphoma, intravascular large B-cell lymphoma, or B-cell lymphoma with features between DLBCL and classical Hodgkin lymphoma.
• People who, in the treating doctor's judgement, urgently need to start chemotherapy immediately — for example, because the tumour is already breaking down on its own or is about to cause organ damage.
• People who have already received cancer treatment for their DLBCL or high-grade B-cell lymphoma (short courses of steroids lasting fewer than 7 days for an unrelated acute problem are allowed).
• People who have had a major surgical procedure within the 30 days before starting the study drug, or who have not yet adequately recovered from a recent surgery.
• People who need to take certain medications that strongly affect how the body processes a specific enzyme pathway (moderate or strong CYP3A inhibitors or inducers) — the trial site can advise on which specific medications this applies to.
• People whose lymphoma has spread to the brain or central nervous system.
• People who are pregnant, or who plan to become pregnant during the study, because the study drugs may harm a developing baby.
• People who are currently breastfeeding, because the effects of the study drugs on nursing infants are unknown and breastfeeding would need to be stopped.
• People with other serious or uncontrolled health conditions, including but not limited to: another cancer currently requiring systemic treatment; an uncontrolled active infection; a condition requiring blood-thinning medication such as warfarin; active bleeding or a known bleeding disorder (such as haemophilia or von Willebrand disease); a serious brain condition called Progressive Multifocal Leukoencephalopathy (PML); active hepatitis C infection (confirmed by a specific blood test); active hepatitis B infection (confirmed by specific blood tests); a history of bleeding stroke or bleeding in the brain within the past 6 months; significant uncontrolled heart problems such as heart failure, uncontrolled irregular heartbeat, or a heart attack within the past 6 months; uncontrolled autoimmune destruction of red blood cells; an inability to swallow tablets or a condition that significantly prevents absorption of oral medications; or a known mental or physical condition that, in the treating doctor's opinion, would interfere with participation in the trial or make involvement inappropriate.
• People who are currently participating in another treatment-based clinical trial.

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