Open label, single arm, multicenter phase II trial.
Preemptive therapy with Venetoclax for high risk stage A Chronic Lymphoid Leukemia patients, a phase II trial of the FILO group. PREVENE (PREemptive VENEtoclax) trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Venetoclax is administered according to the usual schedule an escalating dose from 20 milligram per day the first week, then 50 milligram per day the second week, 100 milligram per day the third week, 200 milligram per day the fourth week and then 400 milligram per day. * For patient achieving a Compete Response with Minimal Residual Disease inferior to 0,01 percent in bone marrow at month 12, treatment will be stopped at month18 (18 months for total duration of treatment ). * For responding patients at month12 (Complete Response or Partial Response) with bone marrow Minimal Residual Disease inferior to 0.01 percent, treatment will be continued until month 24 (24 months for total duration of treatment).
Chu Amiens
Amiens, France
Chu Angers
Angers, France
Complete response rate
according to International Workshop Chronic Lymphoid Leukemia 2008 guidelines and with Minimal Residual Disease inferior to 0.01 percent (as determined by 8-color technique) in bone marrow at month 12.
Time frame: 12 months
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Ch Annecy
Annecy, France
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Bayonne, France
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Besançon, France
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Béziers, France
CH BLOIS
Blois, France
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Bordeaux, France
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Caen, France
Hôpital Privé Sévigné
Cesson-Sévigné, France
...and 13 more locations