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EA9161: A Randomized Phase III Study of the addition ofVenetoclax to Ibrutinib and Obinutuzumab versus Ibrutiniband Obinutuzumab in Untreated Younger Patients withChronic Lymphocytic Leukemia (CLL)
The is a drug study to compare the progression freesurvival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years
Yes
Medicine: Hematology and Medical Oncology (HERSHEY)
All
18 year(s) or older
NCT03701282
SITE00000485
Inclusion Criteria:
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteriaNegative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISHNo active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Cancer