NCT03766763

Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label, single arm, multicenter phase II trial.

Detailed description

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.

Conditions

• Chronic Lymphoid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	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).

Timeline

• Start date: 2019-05-22
• Primary completion: 2022-01-01
• Completion: 2030-04-24
• First posted: 2018-12-06
• Last updated: 2025-11-26

Locations

23 sites across 1 country: France