New Investigation Oral Drug for Previously Treated CLL/SLL Patients

Inclusion Criteria

• Have confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma
• Have been previously treated with at least one line of therapy
• Be agreeable to a screening bone marrow biopsy
• Have one of the following:
• --Development of, or worsening of, anemia and/or thrombocytopenia
• --Massive or progressive or symptomatic splenomegaly (> 13 cm)
• --Massive nodes or progressive or symptomatic lymphadenopathy
• --Progressive lymphocytosis with an increase of > 50% over a 2-month period or lymphocyte doubling time < 6 months
• --Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids
• --Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine)
• --Unintentional weight loss = 10% within the previous 6 months
• --Significant fatigue
• --Fevers of 100.4°F (38.0°C) or higher for 2 or more weeks without evidence of infection
• --Night sweats for 1 month or more without evidence of infection

Exclusion Criteria

• Have known Richter's Transformation, Prolymphocytic Leukemia, or Hodgkin's Lymphoma
• Have previous exposure to Venetoclax or other BCL2 inhibitors
• Be prescribed Warfarin or other Vitamin K antagonist
• Have Central Nervous System involvement
• Have had any major bleeding on previous BTK inhibitor
• Have an active second malignancy
• Have previously received allogenic or autologous SCT or CAR-T therapy in the last 60days
• Be pregnant or planning on becoming pregnant

Additional Info

• Patients will be randomized (like the flip of coin) to standard of care plus the investigational drug or standard of care alone.
• Consumption of grapefruit, grapefruit juice, Seville oranges, and Starfruit is prohibited during the study.
• For more information search for NCT04965493 at www.clinicaltrials.gov