Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®

NCT ID: NCT03287128

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-03-01

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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Gemtuzumab Ozogamicin (GO)

patients included in a compassionate patient named program with GO

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

• Previous treatment with GO
• AML type 3
• More than 1 relapse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ms Juliette LAMBERT

study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

C.H.U. d'Amiens - Hôpital Sud

Amiens, , France

Site Status: RECRUITING

C.H.U. d'Angers

Angers, , France

Site Status: RECRUITING

HIA Percy

Clamart, , France

Site Status: RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status: RECRUITING

Hôpital du Bocage

Dijon, , France

Site Status: RECRUITING

Hôpital André Mignot

Le Chesnay, , France

Site Status: RECRUITING

Hôpital Hotel Dieu

Nantes, , France

Site Status: RECRUITING

Hôpital de la Source

Orléans, , France

Site Status: NOT_YET_RECRUITING

Hopital Saint Louis

Paris, , France

Site Status: NOT_YET_RECRUITING

C.H. Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Hôpital Brabois Adultes

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laure MORISSET

Role: CONTACT

lmorisset@ch-versailles.fr

+33-1-39-23-97-85

Facility Contacts

Magalie JORIS

Role: primary

Mathilde HUNAULT

Role: primary

Jean Valère MALFUSON

Role: primary

Cécile PAUTAS

Role: primary

Denis CAILLOT

Role: primary

Juliette LAMBERT

Role: primary

Pierre PETERLIN

Role: primary

Diana CARP

Role: primary

Emmanuel RAFFOUX

Role: primary

Xavier THOMAS

Role: primary

Caroline BONMATI

Role: primary

Other Identifiers

P1612_MYLOR

Identifier Type: -

Identifier Source: org_study_id