Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT03766763
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Lymphoid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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).

Study Details

Open label, single arm, multicenter phase II trial.

Key Dates

Start date
May 22, 2019
Status verified
Nov 2025
Primary completion
Jan 1, 2022
Completion
Apr 24, 2030

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ARM A VENETOCLAX
    VENETOCLAX

Primary Outcome Measure

Complete response rate [ Time Frame: 12 months ]