Informations générales (source: ClinicalTrials.gov)
A Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®
Observational
Versailles Hospital (Voir sur ClinicalTrials)
novembre 2017
mars 2019
13 septembre 2025
Gemtuzumab Ozogamicin/Mylotarg® (GO) is a conjugate of a derivative of calicheamicin a
potent antitumor anthracycline antibiotic linked to a recombinant humanized antibody
against the CD33 antigen. Pivotal phase 2 study in relapsed AML adult patients used GO 9
mg/m2 as a monotherapy on days 1 and 14, and showed a 30% response rate with half CR and
CRp (CR with incomplete platelets recovery). Four randomized studies, 3 in adults and 1
in children, performed in patients with non-previously treated AML tested the addition of
lower doses of GO ( 3mg or 6 mg/m2) to standard induction chemotherapy and showed benefit
on survival endpoints. Results from these studies were available in 2011 in adults and
2014 in children. In 2010 the french health agency (ANSM) opened a compassionate patient
named program (authorization for temporary utilization (ATU) program) of GO in
relapsed/refractory AML patients. Patients were orally informed about the status of the
GO. From 2010 to 2012 it was recommended to use GO as a monotherapy at a dose of 9mg/m2
on days 1 and 14 according to the protocol used in pivotal phase 2 study. After 2012 it
was recommended by the health authority to use GO at the dose of 3 or 6 mg/m2 in addition
to chemotherapy regarding the toxicity of higher dose given once.
From 2010 to 2015 more than 500 AML patients have been included in this ATU program.
The main objective of the study presented here is to assess the efficacy and safety of GO
3 or 6 mg/m2 (single dose or fractionated GO) given in as treatment of
relapsed/refractory AML in adult patients.
The coordinator choose to collect the data from centers that included 10 patients or more
from January 2012 to December 2015.
This represents approximately 420 patients from 33 hematology departments.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Juliette LAMBERT | 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 | |||||
| C.H. Lyon Sud - Pierre-Bénite - France | Xavier THOMAS | Contact (sur clinicalTrials) | |||
| C.H.U. d'Amiens - Hôpital Sud - Amiens - France | Magalie JORIS | Contact (sur clinicalTrials) | |||
| C.H.U. d'Angers - Angers - France | Mathilde HUNAULT | Contact (sur clinicalTrials) | |||
| HIA Percy - Clamart - France | Jean Valère MALFUSON | Contact (sur clinicalTrials) | |||
| Hôpital Brabois Adultes - Vandoeuvre les nancy - France | Caroline BONMATI | Contact (sur clinicalTrials) | |||
| Hôpital de la Source - Orléans - France | Diana CARP | Contact (sur clinicalTrials) | |||
| Hôpital du Bocage - Dijon - France | Denis CAILLOT | Contact (sur clinicalTrials) | |||
| Hôpital Henri Mondor - Créteil - France | Cécile PAUTAS | Contact (sur clinicalTrials) | |||
| Hôpital Hotel Dieu - Nantes - France | Pierre PETERLIN | Contact (sur clinicalTrials) | |||
| Hopital Saint Louis - Paris - France | Emmanuel RAFFOUX | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient more than 18 year old;
- De novo or secondary leukemia.
- Refractory to standard intensive chemotherapy (defined by the association of
anthracycline and cytarabine, at different doses) or in first relapse.
- Treated with GO from January 2012 to December 2016.
- Patient more than 18 year old;
- De novo or secondary leukemia.
- Refractory to standard intensive chemotherapy (defined by the association of
anthracycline and cytarabine, at different doses) or in first relapse.
- Treated with GO from January 2012 to December 2016.
- Previous treatment with GO
- AML type 3
- More than 1 relapse