Phase 3 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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the past 18 months, confirmed using 2018 international diagnostic guidelines.
• People whose CLL has been assessed using a recognised risk-scoring system (called the CLL-IPI) and received a score of 4 or higher, and/or whose cancer cells show 3 or more chromosome abnormalities.
• People who have had specific chromosome and genetic tests done at an approved laboratory within the past 18 months, including tests looking at certain chromosome regions (13q, 12, 11q, and 17p).
• People who have had a gene mutation test (for a gene called TP53) done at an approved laboratory within the past 18 months, if this test was completed (this test is recommended but not always required).
• People who have had an IgVH gene mutation test done at an approved laboratory at any time before joining the trial.
• People who have had a specific blood protein level test (beta-2 microglobulin) within the past 28 days.
• People whose CLL does not yet meet the standard criteria that would normally require active cancer treatment.
• People who are 18 years of age or older.
• People who are reasonably active and able to care for themselves, based on a standard medical rating scale (ECOG performance status of 0, 1, or 2).
• People whose recent blood test results (taken within 28 days) show:
  • Platelet count of at least 100,000 per mm³
  • Neutrophil count (a type of white blood cell) of at least 1,000 per mm³
  • Kidney function measuring at least 30 mL/min
  • Liver enzyme levels (AST and ALT) below 3 times the normal upper limit
  • A liver marker (total bilirubin) at or below 2 times the normal upper limit (or up to 5 times normal for people with a condition called Gilbert's disease)
• People who are able to swallow and digest oral (tablet or capsule) medications.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of another cancer, provided that cancer has not required active treatment within the past 2 years (ongoing hormonal therapy is allowed). Certain low-risk or treated cancers may also be accepted — the trial site can confirm whether a specific cancer history applies.
• People with a latent (inactive) hepatitis B infection, provided they agree to take preventive anti-hepatitis medication during the trial and for 6 months after active treatment ends.
• People who agree to have blood or tissue samples collected for research purposes as part of the trial.
• People who are willing and able to sign a written consent form confirming they understand the investigational nature of the study.
• People who are able to complete quality-of-life questionnaires in English, Spanish, French, German, Russian, or Mandarin may also be invited to participate in that part of the study (those who do not read or write in these languages may still join the main trial).

Who may not be able to join:

• People who have previously received or are currently receiving any treatment specifically aimed at CLL, including immunotherapy, experimental therapies, or radiation therapy (with a limited exception for certain COVID-19 emergency treatments).
• People who have previously received a type of cancer drug called an anti-CD20 monoclonal antibody.
• People who are currently receiving, or planning to receive, any other experimental treatment during the trial.
• People who have received high-dose steroid treatment or intravenous immunoglobulin (IVIG) for CLL-related immune complications within the past 4 weeks.
• People currently taking steroids for conditions other than CLL at a dose higher than 20 mg per day of prednisone (or an equivalent steroid).
• People who have significant problems absorbing food or medication through the digestive system, in the opinion of their treating doctor.
• People who have cirrhosis (serious scarring of the liver).
• People with an active, uncontrolled hepatitis B or C infection (meaning the virus is currently detectable in their blood).
• People who have had major surgery (such as joint replacement or surgery inside the chest or abdomen) within the past 30 days, or minor surgery (such as a skin biopsy or dental procedure) within the past 7 days.
• People with known bleeding disorders, such as von Willebrand's disease or haemophilia.
• People who have had a stroke or bleeding in the brain within the past 6 months.
• People who need to continue taking certain medications that strongly affect the way a key trial drug (venetoclax) is processed by the body (confirm specific medications with the trial site).
• People with uncontrolled immune-related blood conditions, such as autoimmune haemolytic anaemia or immune thrombocytopenic purpura (ITP).
• People with currently active, serious heart problems, such as uncontrolled irregular heartbeat or severe heart failure (classified as Class 3 or 4 by a standard heart failure rating system).
• People who have had a heart attack, unstable chest pain, or acute coronary syndrome within the past 6 months.
• People who are currently pregnant or breastfeeding, as the safety of the trial drugs in pregnancy is not established.
• People of reproductive potential who are not willing to use effective contraception during the trial period, as required by the protocol.

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