Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The names of the study drugs involved in this study are:
* obinutuzumab * venetoclax * acalabrutinib
Eligibility criteria
Qualifiers
Diagnosis of CLL or SLL according to WHO criteria
Participants must require therapy according to iwCLL 2018 guidelines
Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL
Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point
Disqualifiers
Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible.
Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator
Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)
Trial design
Treatments tested in this trial
- Venetoclax
- Obinutuzumab
- Acalabrutinib
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov