Status:
Recruiting
Diagnosis:
- Chronic Lymphocytic Lymphoma
Phase:
Official Title:
A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab in Untreated Older Patients (>/=70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
NCT ID:
NCT#03737981
Link to Full Details:
Investigators:
- Dr. Mark Olsen
Description:
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer 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 cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Eligibility:
Male and Female – 70 years and older
Inclusion Criteria:
- CLL diagnosis in accordance with 2018 IWCLL criteria
- Intermediate or high-risk Rai stage CLL
- No prior therapy for CLL
Exclusion Criteria:
- Age less than 70 years
- Active systemic anticoagulation
- MI, intracranial bleed, or stroke within past 6 months