New Investigation Oral Drug for Previously Treated CLL/SLL Patients

Trial ID:
Marin Xavier, MD
This is a phase 3 open-label, randomized study to assess the safety and effectiveness of a fixed duration of the investigational study drug plus standard of care treatment versus standard care alone.

Inclusion Criteria

Patients must:

  • 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

Patients must not:

  • 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

Contact Info:

  • Clinical Research Services