Chronic Lymphoid LeukemiaPhase 2NCT03766763
Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A
A Phase 2 study testing Venetoclax in people with Chronic Lymphoid Leukemia, run by French Innovative Leukemia Organisation at 23 sites in France.
Trial summary
Open label, single arm, multicenter phase II trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphoid Leukemia
- What is being tested?
- Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 23 sitesFrance
- Study dates
- 22 May 2019to 24 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 exclusion criteria)
- Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Chronic Lymphoid Leukemia prior to the study
- Medical condition requiring the long term (estimated to be more than one month) use of oral corticosteroids
- Patient refusal to perform the bone marrow biopsy for evaluation points
- Patients with active bacterial, viral or fungal infection
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- Subject is known to be positive for Human Immunodeficiency Virus
- Evidence of other clinically significant uncontrolled conditions
- Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
- A female patient who is pregnant or breast feeding
- Concurrent severe diseases which exclude the administration of therapy
- Richter's syndrome
- Treatment with any of the following within 7 days prior to the first dose of study drug: Steroid therapy for anti-neoplastic intent, moderate or strong cytochrome P450 3A inhibitors, moderate or strong cytochrome P450 3A inducers
- Administration or consumption of any of the following within 3 days prior to the first dose of study drug: grapefruit or grapefruit products, Seville oranges, star fruit.
- Prior and concomitant therapy
- Malabsorption syndrome or other condition that precludes enteral route of administration
- Received a live viral vaccination within 6 months prior to the first dose of study drug. A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes
- Major surgery within 30 days prior to the first dose of study treatment
- History of prior other malignancy that could affect compliance with the protocol or interpretation of results
- Not affiliated to social security
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Chu Amiens
Amiens, 80054
Chu Angers
Angers, 49933
Ch Annecy
Annecy, 74374
Ch Cote Basque
Bayonne, 64109
Hopitaljean Minjoz
Besançon, 25000
Ch Beziers
Béziers, 34500
CH BLOIS
Blois, 41000
Institut Bergonie
Bordeaux, 33076
CHU CAEN
Caen, 14033
Hôpital Privé Sévigné
Cesson-Sévigné, 35510
Chu Estaing
Clermont-Ferrand, 63000
Chu Creteil
Créteil, 94000
Chu Grenoble
Grenoble, 38043
Chd Vendee
La Roche-sur-Yon, 85925
Chd Le Mans
Le Mans, 72000
Hopital Huriez
Lille, 59037
Centre leon berard
Lyon, 69008
Institut Paoli Calmette
Marseille, 130009
Centre Hospitalier Regional Metz Thionville
Metz, 57085
Bordeaux Pessac
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Henri Becquerel - Service Hématologie Clinique
Rouen, 76038
Hôpital Bretonneau - Hématologie et Thérapie Cellulaire
Tours, 37044
About this study
Official title: Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO
Open label, single arm, multicenter phase II trial.
Read the 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
- Being tested
- Venetoclax
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
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 group | Role | What they receive |
|---|---|---|
| ARM A VENETOCLAX | Experimental | VENETOCLAX Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start22 May 2019
- Primary completion1 Jan 2022
- Study completion24 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphoid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LEVY, MD PD, Principal investigator, French Innovative Leukemia OrganisationLuc-Matthieu FORNECKER, MD, Study chair, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766763
- Sponsor's protocol ID
- PREVENE FILOCLL10
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2018
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: eCRF
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO
- ClinicalTrials.gov ID
- NCT03766763
- Acronym / sponsor ID
- PREVENE FILOCLL10
- Conditions
- Chronic Lymphoid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 24 Apr 2030 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM A VENETOCLAX | Experimental | Drug: VenetoclaxVENETOCLAX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (20 listed)
- 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 exclusion criteria)
- Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Chronic Lymphoid Leukemia prior to the study
- Medical condition requiring the long term (estimated to be more than one month) use of oral corticosteroids
- Patient refusal to perform the bone marrow biopsy for evaluation points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxVenetoclax 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). | Drug | ARM A VENETOCLAX |
Primary outcome
Complete response rate
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- French Innovative Leukemia Organization (FILO) internet siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. eCRF
Related trials for Chronic Lymphoid Leukemia
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RecruitingPhase 2
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia (SLL)
Active, not recruitingPhase 3
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Leukemia, Lymphocytic, Chronic, B-Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent LEVY, MD PD principal investigator
French Innovative Leukemia Organisation
Luc-Matthieu FORNECKER, MD study chair
French Innovative Leukemia Organisation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax in people with Chronic Lymphoid Leukemia, run by French Innovative Leukemia Organisation at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.