Chronic Lymphoid Leukemia
Conditions
Brief 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.
Interventions
DRUGVenetoclax
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).
Sponsors
French Innovative Leukemia Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established diagnosis of Chronic Lymphoid Leukemia by International Workshop Chronic Lymphoid Leukemia 2008 criteria with Matutes score Superior to 3, or Matutes score egal to 3 with CD200 positive and CD20 low * High risk Binet stage A, patients presenting at least 2 from 3 risk factors: Lymphocytosis Superior to 13 Giga per liter, CD38 positive, beta2 microglobulin Superior to 2.5 milligram per liter. Only patients with unmutated status will be treated and followed according to the trial. * No prior chemotherapy, radiation or antibody treatment * Age Superior to 18 years * Life expectancy Superior to 6 months * Performance status 0 to 2 * All parameters for risk stratification present * Possibility of follow-up * Adequate hepatic function per local laboratory reference range as follows: Aspartate transaminase and alanine transaminase Superior to 3.0 of upper limit of normal and Bilirubin inferior or egal to 1.5 of upper limit of normal (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin). * Willingness to accept highly effective methods of contraception for the duration of therapy and 12 months thereafter * Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at Screening. * Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Exclusion criteria
* Binet Stage A patients with progressive disease according to International Workshop Chronic Lymphoid Leukemia 2008 criteria * Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive hemolytic anemia (positive antiglobulin test without anemia is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 12 months | 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. |
Countries
France
Outcome results
None listed