Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®
MYLOR
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®
1 other identifier
observational
300
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJanuary 24, 2018
September 1, 2017
11 months
September 15, 2017
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
45 days
Secondary Outcomes (7)
Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.
2 years
Duration of second remission
2 years
Relapse Free Survival defined as the time from onset of GO retreatment for relapsed/refractory AML to the first event (death or relapse).
2 years
Cumulative incidence of early deaths
60 days
Grade 3 to 5 liver, infectious and cardiac adverse events
45 days
- +2 more secondary outcomes
Interventions
patients included in a compassionate patient named program with GO
Eligibility Criteria
Retrospective cohort, using medical charts of relapsing or refractory patients after intensive chemotherapy included in a compassionate patient named program of Gemtuzumab Ozogamicin from January 2012 to December 2015 and treated in 30 centers to evaluate the efficacy and safety of Gemtuzumab Ozogamicin (GO) given in addition to chemotherapy.
You may qualify if:
- 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.
You may not qualify if:
- Previous treatment with GO
- AML type 3
- More than 1 relapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
C.H.U. d'Amiens - Hôpital Sud
Amiens, France
C.H.U. d'Angers
Angers, France
HIA Percy
Clamart, France
Hôpital Henri Mondor
Créteil, France
Hôpital du Bocage
Dijon, France
Hôpital André Mignot
Le Chesnay, France
Hôpital Hotel Dieu
Nantes, France
Hôpital de la Source
Orléans, France
Hopital Saint Louis
Paris, France
C.H. Lyon Sud
Pierre-Bénite, France
Hôpital Brabois Adultes
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- study Coordinator
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
November 1, 2017
Primary Completion
October 1, 2018
Study Completion
March 1, 2019
Last Updated
January 24, 2018
Record last verified: 2017-09