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Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03766763
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : June 21, 2019
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Brief Summary:
Open label, single arm, multicenter phase II trial.

Condition or disease Intervention/treatment Phase
Chronic Lymphoid Leukemia Drug: Venetoclax Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2028

Arm Intervention/treatment
Experimental: ARM A VENETOCLAX
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).

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03766763

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Contact: Delphine NOLLET (33) 2 18 37 06 09

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Chu Amiens Not yet recruiting
Amiens, France, 80054
Contact: Caroline DELETTE, MD    +33322455914   
Chu Angers Not yet recruiting
Angers, France, 49933
Contact: Aline CLAVERT, MD    +33 2 41 35 45 24   
Ch Annecy Not yet recruiting
Annecy, France, 74374
Contact: Stéphanie TARDY, MD    +334 50 63 66 08   
Ch Cote Basque Not yet recruiting
Bayonne, France, 64109
Contact: Julie GAY, MD    +33559443832   
Hopitaljean Minjoz Not yet recruiting
Besançon, France, 25000
Contact: Annie BRION, MD    +33381668232   
CH BLOIS Not yet recruiting
Blois, France, 41000
Contact: Abderrazak EL YAMANI, MD    +33254556405   
Institut Bergonie Not yet recruiting
Bordeaux, France, 33076
Contact: Fontanet BIJOU, MD    +33556330448   
Ch Beziers Not yet recruiting
Béziers, France, 34500
Contact: Alain SAAD, MD    +33467357063   
CHU CAEN Not yet recruiting
Caen, France, 14033
Contact: Jean-Pierre VILQUE, MD    +33231272759   
Chu Estaing Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Romain Guieze, MD    +33473750766   
Chu Creteil Recruiting
Créteil, France, 94000
Contact: Jehan DUPUIS, MD    +33149812051   
Chu Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Lysiane MOLINA, MD    +33476765455   
Chd Vendee Not yet recruiting
La Roche-sur-Yon, France, 85925
Contact: Bruno Villemagne, MD    +33251446173   
Chd Le Mans Not yet recruiting
Le Mans, France, 72000
Contact: Kamel LARIBI, MD    +33243434361   
Hopital Huriez Not yet recruiting
Lille, France, 59037
Contact: Franck Morschhauser, MD    +33220445713   
Centre leon berard Not yet recruiting
Lyon, France, 69008
Contact: Anne-Sophie MICHALLET, MD    +33478783737   
Institut Paoli Calmette Not yet recruiting
Marseille, France, 130009
Contact: Thérèse AURRAN, MD    +33491223667   
Centre Hospitalier Regional Metz Thionville Not yet recruiting
Metz, France, 57085
Contact: Philippe CARASSOU, MD    +333 87 55 33 63   
Bordeaux Pessac Not yet recruiting
Pessac, France, 33604
Contact: Marie-Sarah DILHUYDY, MD    +33557656511   
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre-Bénite, France, 69495
Contact: Emmanuelle FERRANT, MD    +33478864521   
Sponsors and Collaborators
French Innovative Leukemia Organisation
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Principal Investigator: Vincent LEVY, MD PD French Innovative Leukemia Organisation
Study Chair: Luc-Matthieu FORNECKER, MD French Innovative Leukemia Organisation

Additional Information:
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Responsible Party: French Innovative Leukemia Organisation Identifier: NCT03766763     History of Changes
Other Study ID Numbers: PREVENE FILOCLL10
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: eCRF

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents