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Etude : PONALLO /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : PONALLO

Nom :

Traitement : Maintenance

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 24/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Phase 2 Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The main goal of this study will be to determine the maximal tolerated dose (MDT) of ponatinib after allo-SCT in FLT3-ITD AML patients, then to investigate the efficacy of ponatinib in a larger cohort of patients

Study arm:
Experimental: Experimental: Administration of ponatinib after allo-SCT transplant in FLT3-ITD AML patient
Intervention: Drug: Ponatinib 30 MG


Current primary outcome:
Relapse incidence at 2 years from transplant [ Time Frame: 2 years ]

Current secondary outcomes:
- Overall survival [ Time Frame: 2 years ]
- Leukemia free survival [ Time Frame: 2 years ]
- Non-relapse mortality (NRM) [ Time Frame: day 100 ]
- Acute and chronic GVHD [ Time Frame: 2 years ]
- Influence of Ponatinib on Immune reconstitution PB lymphocyte cells [ Time Frame: 1 years ]
- Inflence of Ponatinib on Chimerism of Donor peripheral blood and CD3 T cells [ Time Frame: 1 years ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]

Phase : II

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Engraftment
- Controlled GVHD
- Positive FLT-3 ITD AML in cytologic complete remission
- Have an Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Have adequate renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for institution
- Have adequate hepatic function: Total serum bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome; Alanine aminotransferase (ALT) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic infiltration of the liver is present ; Aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic infiltration of the liver is present
- Have normal pancreatic status: Serum lipase and amylase ≤ 1.5 × ULN
- Have normal QTcF interval on screening electrocardiogram (ECG) evaluation,defined as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.
- Platelets ≥ 100 Giga/l; Neutrophils ≥ 1 Giga/l
- Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential).
- Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile).
- Provide written informed consent.
- Be willing and able to comply with scheduled visits and study procedures.

Critères de non-inclusion : - HIV positive, active Hepatitis B or C
- Childbearing or childbreast feeding women
- Women or men without effective contraceptive barrier if needed
- Previous myocardial infarction, or cerebral vascular accident, pancreatitis
- Respiratory insufficiency defined as DLCO <40% of the corrected value
- Creatinine clearance ≤ 50ml/min
- Contra-indication to ponatinib
- Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients at high or very high risk of cardiovascular disease with any of the following:
1) Established cardiovascular disease Cardiac disease:
* Congestive heart failure greater than class II NYHA or
* Left ventricular ejection fraction (LVEF) < 50% or
* Unstable angina (anginal symptoms at rest) or
* New onset angina (began within the last 3 months) or
* Myocardial infarction, coronary/peripheral artery disease, congestive heart failure, cerebrovascular accident including transient ischemic attack within the past 12 months or
* History of thrombolic or embolic events Arrhythmias
* Any history of clinically significant cardiac arrhythmias requiring anti-arrhythmic therapy.
2) Diabetes Mellitus,
3) Arterial Hypertension,
* Uncontrolled hypertension defined as systolic blood pressure greater than 140 mmHg or diastolic pressure greater than 90 mmHg, despite optimal medical management and optimal measurement (http://www.has-sante.fr/portail/display.jsp?id=c_272459)
* Any history of hypertension with
* Hypertensive encephalopathy
* Posterior leucoencephalopathy
* Aortic or artery dissection
4) Familial dysplipidemia.
5) Taking medications that are known to be associated with Torsades de Pointes
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03690115
Promoteur :
CH VERSAILLES
Type de sponsor : Institutionnel
177 Rue de Versailles
78000 VERSAILLES

Coordonnateur :
Professeur patrice CHEVALLIER
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Anne-Lise MENARD

TEC / ARC / IDE :
stéphanie SERIS
stephanie.seris@
chb.unicancer.fr
02.32.08.24.98

Statut de l'essai : OUVERT

MAJ : 24/01/2020