Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

NCT03766763 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PREVENE FILOCLL10
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 23

Brief Summary

Open label, single arm, multicenter phase II trial.

Conditions

Chronic Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

ARM A VENETOCLAX

EXPERIMENTAL

VENETOCLAX

Drug: Venetoclax

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).

ARM A VENETOCLAX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Binet Stage A patients with progressive disease according to International Workshop Chronic Lymphoid Leukemia 2008 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
• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

Study Sites (23)

Chu Amiens

Amiens, 80054, France

Location

Chu Angers

Angers, 49933, France

Location

Ch Annecy

Annecy, 74374, France

Location

Ch Cote Basque

Bayonne, 64109, France

Location

Hopitaljean Minjoz

Besançon, 25000, France

Location

Ch Beziers

Béziers, 34500, France

Location

CH BLOIS

Blois, 41000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU CAEN

Caen, 14033, France

Location

Hôpital Privé Sévigné

Cesson-Sévigné, 35510, France

Location

Chu Estaing

Clermont-Ferrand, 63000, France

Location

Chu Creteil

Créteil, 94000, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

Chd Vendee

La Roche-sur-Yon, 85925, France

Location

Chd Le Mans

Le Mans, 72000, France

Location

Hopital Huriez

Lille, 59037, France

Location

Centre leon berard

Lyon, 69008, France

Location

Institut Paoli Calmette

Marseille, 130009, France

Location

Centre Hospitalier Regional Metz Thionville

Metz, 57085, France

Location

Bordeaux Pessac

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel - Service Hématologie Clinique

Rouen, 76038, France

Location

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

Tours, 37044, France

Location

Related Links

• French Innovative Leukemia Organization (FILO) internet site

MeSH Terms

Conditions

Leukemia, B-Cell

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Vincent LEVY, MD PD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

• Luc-Matthieu FORNECKER, MD

  French Innovative Leukemia Organisation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: May 22, 2019
• Primary Completion: January 1, 2022
• Study Completion (Estimated): April 24, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23)