This research study is trying to determine which patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely tolerate an accelerated, daily venetoclax dose ramp-up rather than the standard approved schedule (5-week dose ramp-up).
The name of the study drug involved in this study is:
* Venetoclax
The following drugs may also be included in some participants treatment regimen:
* Obinutuzumab
* Rituximab
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma per IW-CLL 201814 requiring therapy based on at least one of the following criteria as listed below:
* Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin \<11.0 g/L) and/or thrombocytopenia (platelets \<100 x 109/L)
* Massive (≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly
* Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic
* lymphadenopathy
* Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of \<6 months. Lymphocyte doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months.
* Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
* Documented constitutional symptoms, defined as 1 or more of the following disease related symptoms or signs: unintentional weight loss \>10% within 6 months prior to screening, significant fatigue (inability to work or perform usual activities), fevers \>100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection, night sweats for more than 1 month prior to screening without evidence of infection
* Both previously untreated and relapsed or refractory patients will …
What they're measuring
1
Highest risk TLS group that can safely tolerate the daily ramp up