New Investigation Oral Drug for Previously Treated CLL/SLL Patients

Trial ID:

IRB-22-7916

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

*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

Contact Info:

• Clinical Research Services
• CRSLeadership@scrippshealth.org