At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) that is treatment-naïve
- ✓Indication for treatment per 2018 IWCLL Criteria
- ✓ECOG performance status 0-2
- ✓Adequate renal function: creatinine clearance >30 mL/min by Cockcroft-Gault (unless disease-related)
- ✕Prior CLL or SLL treatment of any kind
- ✕Known HIV infection or any uncontrolled active significant infection (bacterial, viral, or fungal)
- ✕Active hepatitis B (HBsAg+ or HBV PCR+) or hepatitis C (HCV PCR+)
- ✕Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intermittent Therapy With the BTK Inhibitor Acalabrutinib (Calquence) in Combination With Obinutuzumab in Treatment Naive (Tn) Patients With Chronic Lymphocytic Leukemia (CLL)
In Brief
A Phase 2 clinical trial evaluating Acalabrutinib and Obinutuzumab for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Active but no longer recruiting, targeting 60 participants across 1 site.
Detailed Summary
This phase II trial investigates the how well acalabrutinib and obinutuzumab work in treating patients with chronic lymphocytic leukemia (CLL). Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and obinutuzumab may help to control disease progression in CLL patients who have not received treatment for CLL.
Study Details
Timeline
Arms & Interventions
Patients receive acalabrutinib PO BID every 12 hours starting on day 1 of cycle 1, and obinutuzumab IV over 4-6 hours on days 1 and 2 of cycle 3, and day 1 of cycles 4-8. Patients who do not achieve a complete response or remission after cycle 8 may receive single-agent acalabrutinib therapy PO BID for an additional 6 cycles at the discretion of their treating physician. Patients who are in partial response or who have stable disease receive an additional 6 cycles of acalabrutinib PO BID and obinutuzumab IV. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV