Leukemia, Myeloid, Acute Clinical Trial
Official title:
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®
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.
n/a
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