Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A
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| ClinicalTrials.gov Identifier: NCT03766763 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2018
Last Update Posted : July 27, 2022
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Sponsor:
French Innovative Leukemia Organisation
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
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Brief Summary:
Open label, single arm, multicenter phase II trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphoid Leukemia | Drug: Venetoclax | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 82 participants |
| Allocation: | N/A |
| 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 |
| Actual Primary Completion Date : | January 22, 2022 |
| Estimated Study Completion Date : | February 1, 2028 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Venetoclax
| Arm | Intervention/treatment |
|---|---|
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Experimental: ARM A VENETOCLAX
VENETOCLAX
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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.
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Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT03766763
Contacts
| Contact: Delphine NOLLET | (33) 2 18 37 06 09 | d.nollet@chu-tours.fr |
Locations
Show 23 study locations
Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
| Principal Investigator: | Vincent LEVY, MD PD | French Innovative Leukemia Organisation | |
| Study Chair: | Luc-Matthieu FORNECKER, MD | French Innovative Leukemia Organisation |
Additional Information:
| Responsible Party: | French Innovative Leukemia Organisation |
| ClinicalTrials.gov Identifier: | NCT03766763 |
| Other Study ID Numbers: |
PREVENE FILOCLL10 |
| First Posted: | December 6, 2018 Key Record Dates |
| Last Update Posted: | July 27, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | eCRF |
| 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 Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes Venetoclax Antineoplastic Agents |