Status:
Recruiting
Disease Site:
Leukemia
Phase:
Official Title:
A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Patients (≥70 Years of Age) with Chronic Lymphocytic Leukemia
NCT ID:
NCT#03516279
Link to Full Details:
Description:
Active Comparator: Arm I (ibrutinib, obinutuzumab) Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (ibrutinib, obinutuzumab, venetoclax) Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity. All patients will then receive a 15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3 cycles for 6 years, then every 6 cycles thereafter.
Eligibility:
Male and Female – 70 years and older
Inclusion Criteria:
- CLL diagnosis and have greater than 5000 B-cell uL of peripheral blood at any point during the course of their disease
- Patients must be intermediate or high-risk Rai stage CLL
- Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines
- Must not have received any prior treatment for CLL
- Age ≥70 years old
Exclusion Criteria:
- Must not have any history of Richter’s transformation or prolymphocytic leukemia