Phase 2 Leukaemia 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 who have been diagnosed with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — meaning the disease came back or stopped responding to treatment — and whose condition meets recognised international diagnosis guidelines.
• People whose disease currently needs treatment, based on established medical guidelines.
• People with SLL who have a measurable amount of disease, such as an enlarged lymph node, an enlarged liver or spleen, or a high number of certain white blood cells in the blood.
• People with SLL who have enlarged lymph nodes and do not have low blood cell counts caused by cancer cells filling the bone marrow.
• People whose CLL or SLL has returned or stopped responding after at least one previous round of treatment.
• People in Cohort 1 must have a specific genetic change called a 17p deletion, confirmed by a central laboratory test.
• People in Cohort 2 must have disease that stopped responding to a class of treatments called B-cell receptor signaling pathway inhibitors (BCRI), AND either: their disease also stopped responding to a type of combined chemotherapy-immune treatment (chemoimmunotherapy), OR they are not considered suitable for that type of treatment (for example, due to having a 17p deletion or a TP53 gene mutation, having significant other illnesses, having reduced kidney function, or other reasons the treating doctor considers relevant).
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out at least some daily activities.
• People whose bone marrow, blood clotting, kidney, and liver function are all within acceptable ranges at the time of screening.
• People who do not have an active COVID-19 infection at the time of joining.

Who may not be able to join:

• People who have previously had an allogeneic stem cell transplant (a transplant using stem cells from another person).
• People whose CLL/SLL has transformed into a more aggressive type of cancer called Richter's transformation, confirmed by a biopsy.
• People who have a related blood cancer called prolymphocytic leukemia.
• People who have active and uncontrolled autoimmune conditions that affect blood cells — such as autoimmune hemolytic anemia or immune thrombocytopenic purpura — that have been present in the two weeks before screening.
• People who have previously been treated with venetoclax or any other BCL-2 inhibitor medication.
• People who have tested positive for HIV.
• People who received a biological cancer treatment within the 30 days before starting the study drug.
• People who received any cancer treatment — including chemotherapy, immunotherapy, radiation therapy, targeted medicines, or experimental treatments — within 14 days or 5 half-lives (whichever is shorter) before starting venetoclax, or who have not sufficiently recovered from side effects of their previous treatment.
• People who are allergic to both xanthine oxidase inhibitors and rasburicase (two types of medications used to manage a potential side effect of cancer treatment).

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