A Phase 2 Study of MRD Adapted Therapy With Venetoclax-obinutuzumab in Patients With High or Intermediate BALL Risk Relapsed or Refractory CLL, With Addition of Acalabrutinib in Patients Who Fail to Achieve MRD Eradication
Massachusetts General Hospital
Summary
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
Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The U.S. Food and Drug Administration (FDA) has approved \[1\] venetoclax- obinutuzumab and \[2\] acalabrutinib individually as treatment options for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). However, the combination of all 3 drugs has not yet been approved by the FDA. * Venetoclax is a targeted therapy drug th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 BALL Risk Model: * Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point * Lactate dehydrogenase If \>institutional upper limit of normal, assign 1 point * Hemoglobin If \<11 g/dL (female) or \<12 g/dL (male), assign 1 point * Time from start of last therapy If \<24 months, assign 1 point, If 4 points, patient is high risk, If 2-3 points, patient is intermediate r…
Interventions
- DrugVenetoclax
Tablet, taken by mouth
- DrugObinutuzumab
Intravenous infusion
- DrugAcalabrutinib
Capsule, taken by mouth
Locations (3)
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts