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

Leukemia, Myeloid, Acute Clinical Trial

— MYLOR  

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®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03287128
• Other study ID #: P1612_MYLOR
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: January 23, 2018
• Start date: November 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2017
• Source: Versailles Hospital
• Contact: Laure MORISSET
• Phone: +33-1-39-23-97-85
• Email: lmorisset[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Gemtuzumab Ozogamicin (GO)
patients included in a compassionate patient named program with GO

Locations

Country	Name	City	State
France	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	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).		45 days
Secondary	Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.		2 years
Secondary	Duration of second remission		2 years
Secondary	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
Secondary	Cumulative incidence of early deaths		60 days
Secondary	Grade 3 to 5 liver, infectious and cardiac adverse events		45 days
Secondary	Severe adverse events during induction treatment		45 days
Secondary	Cumulative incidence of allogenic transplant among responder's patients with respects to age.		2 years