Informations générales (source: ClinicalTrials.gov)
OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS - PONAZA TRIAL (PONAZA)
Interventional
Phase 2
Versailles Hospital (Voir sur ClinicalTrials)
juin 2019
décembre 2024
07 décembre 2024
This project is strategy aiming to improve the survival of patients with chronic
myelogenous leukemia in advanced phase and myeloid blast crisis.
The basis of this strategy is to add the demethylating agent 5-Azacitidine to the
tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients
with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Thorsten BRAUN | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | Madalina UZUNOV | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Simona LAPUSAN | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Philippe ROUSSELOT | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henri Becquerel - Rouen - France | Pascal LENAIN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Annecy Genevois - Pringy - France | Pascale CONY-MAKHOUL | Contact (sur clinicalTrials) | |||
| Centre Hospitalier D'Avignon - Avignon - France | Harcène ZERAZHI | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Caen-Normandie - Caen - France | Sylvain CHANTEPIE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de La Cote Basque - Bayonne - France | Frédéric BAUDUER | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Perpignan - Perpignan - France | Fabienne VACHERET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Strasbourg - Strasbourg - France | Shanti NATARAJAN-AME | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Metropole Savoie - Chambéry - France | Gian Matteo PICA | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Regional Universitaire de Lille - Lille - France | Bruno QUESNEL | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire D'Amiens - Amiens - France | Delphine LEBON | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Dijon - Dijon - France | Marie-Lorraine CHRETIEN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Rennes - Rennes - France | Martine ESCOFFRE- BARBE | Contact (sur clinicalTrials) | |||
| Chru de Nancy - Vandœuvre-lès-Nancy - France | Agnes GUERCI-BRESLER | Contact (sur clinicalTrials) | |||
| Hopital St Louis - Paris - France | Emmanuel RAFFOUX | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Pierre-Bénite - France | Marie BALSAT | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Bordeaux - France | Gabriel ETIENNE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Clermont Ferrand - Clermont-Ferrand - France | Eric HERMET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Grenoble - Grenoble - France | Stéphane COURBY | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Limoges - Limoges - France | Pascal TURLURE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes - Nantes - France | Viviane DUBRUILLE | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - Lyon - France | Franck NICOLINI | Contact (sur clinicalTrials) | |||
| Hopital Bicetre - Le Kremlin-Bicêtre - France | Ali TURHAN | Contact (sur clinicalTrials) | |||
| Hopital Henri Mondor - Créteil - France | Lydia ROY | Contact (sur clinicalTrials) | |||
| Institut Universitaire Du Cancer Toulouse - Toulouse - France | Suzanne TAVITIAN | Contact (sur clinicalTrials) | |||
| Intitut Gustave Roussy - Villejuif - France | Stéphane DE BOTTON | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patient aged 18 years or more
2. Signed informed consent
3. Patient with Philadelphia chromosome positive CML in first blast crisis or first
accelerated phase:
- AP-CML is defined by the presence of any of the following features:
- 15-29% blasts in peripheral blood (PB) or bone marrow (BM)
- ≥ 20% basophils in PB
- ≥ 30% blasts plus promyelocytes (with blasts <30%) in PB or BM,
- <100 x10(9)/L platelets unrelated to therapy, or by clonal cytogenetics
evolution (i.e., the presence of cytogenetic abnormalities other than the
Philadelphia chromosome);
- MBC-CML is defined by the presence of ≥ 30% blasts in the bone marrow and/or
peripheral blood or the presence of extramedullary disease.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
5. Have adequate renal function as defined by the following criterion: Serum creatinine
≤ 1.5 × upper limit of normal (ULN) for institution
6. Have adequate hepatic function as defined by the following criteria:
1. Total serum bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome or CML
2. Alanine aminotransferase (ALT) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic
infiltration of the liver is present
3. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic
infiltration of the liver is present
7. Have normal pancreatic status as defined by the following criterion: Serum lipase
and amylase ≤ 1.5 × ULN
8. Have normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined
as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.
9. Have a negative pregnancy test documented prior to enrollment (for females of
childbearing potential).
10. Agree to use an effective form of contraception with sexual partners throughout
study participation (for female and male patients who are fertile).
11. Have fully recovered (≤ grade 1, returned to baseline, or deemed irreversible) from
the acute effects of prior cancer therapy before initiation of study drug
1. Patient aged 18 years or more
2. Signed informed consent
3. Patient with Philadelphia chromosome positive CML in first blast crisis or first
accelerated phase:
- AP-CML is defined by the presence of any of the following features:
- 15-29% blasts in peripheral blood (PB) or bone marrow (BM)
- ≥ 20% basophils in PB
- ≥ 30% blasts plus promyelocytes (with blasts <30%) in PB or BM,
- <100 x10(9)/L platelets unrelated to therapy, or by clonal cytogenetics
evolution (i.e., the presence of cytogenetic abnormalities other than the
Philadelphia chromosome);
- MBC-CML is defined by the presence of ≥ 30% blasts in the bone marrow and/or
peripheral blood or the presence of extramedullary disease.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
5. Have adequate renal function as defined by the following criterion: Serum creatinine
≤ 1.5 × upper limit of normal (ULN) for institution
6. Have adequate hepatic function as defined by the following criteria:
1. Total serum bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome or CML
2. Alanine aminotransferase (ALT) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic
infiltration of the liver is present
3. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic
infiltration of the liver is present
7. Have normal pancreatic status as defined by the following criterion: Serum lipase
and amylase ≤ 1.5 × ULN
8. Have normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined
as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.
9. Have a negative pregnancy test documented prior to enrollment (for females of
childbearing potential).
10. Agree to use an effective form of contraception with sexual partners throughout
study participation (for female and male patients who are fertile).
11. Have fully recovered (≤ grade 1, returned to baseline, or deemed irreversible) from
the acute effects of prior cancer therapy before initiation of study drug
1. Pregnant or lactating women,
2. Participation in another clinical trial with any investigative drug within 30 days
prior to study enrolment,
3. Prior history of hematopoietic stem cell transplantation
4. Cardiovascular disease:
- Stage II to IV congestive heart failure (CHF) as determined by the New York
Heart Association (NYHA) classification system for heart failure.
- Myocardial infarction within the previous 6 months
- Symptomatic cardiac arrhythmia requiring treatment
5. Individuals with another active malignancy
6. Patients at high risk or very high risk of arterio-veinous occlusive disease defined
by European CVD score
7. Previous treatment with azacitidine,
8. Diagnosis of malignant disease within the previous 12 months (excluding base cell
carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy
excised or irradiated with a high probability of cure)
9. Known active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis
type B or C