Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZulfa Omer
About this trial
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Eligibility criteria
Qualifiers
Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL/SLL diagnosis that requires therapy by one IWCLL criteria; and, must be previously untreated CLL/SLL.
Men and Women ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
ANC ≥1,000/mcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500/mcL unless WBC is > to 50 x 109/L. If WBC is > to 50 x 109/L there will be no lower threshold of ANC. Use of steroids for disease control is allowed.
Disqualifiers
Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
Patients with active Richter's transformation.
History of or ongoing confirmed central nervous system (CNS) lymphoma.
Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
Trial design
Treatments tested in this trial
- Venetoclax
- Acalabrutinib
- Venetoclax
- Acalabrutinib
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zulfa Omer
Lead sponsor
University of Cincinnati
Sponsor institution
Source ClinicalTrials.gov