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Trial record 1 of 1 for:    PREVENE
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Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

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ClinicalTrials.gov Identifier: NCT03766763
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE May 22, 2019
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03766763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A
Official Title  ICMJE Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphoid Leukemia
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: ARM A VENETOCLAX
VENETOCLAX
Intervention: Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2028
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Delphine NOLLET (33) 2 18 37 06 09 d.nollet@chu-tours.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03766763
Other Study ID Numbers  ICMJE PREVENE FILOCLL10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: eCRF
Responsible Party French Innovative Leukemia Organisation
Study Sponsor  ICMJE French Innovative Leukemia Organisation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent LEVY, MD PD French Innovative Leukemia Organisation
Study Chair: Luc-Matthieu FORNECKER, MD French Innovative Leukemia Organisation
PRS Account French Innovative Leukemia Organisation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP