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

January 23, 2018 updated by: Ms Juliette LAMBERT, Versailles Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • C.H.U. d'Amiens - Hôpital Sud
        • Contact:
          • Magalie JORIS
      • Angers, France
        • Recruiting
        • C.H.U. d'Angers
        • Contact:
          • Mathilde Hunault
      • Clamart, France
        • Recruiting
        • HIA Percy
        • Contact:
          • Jean Valère MALFUSON
      • Créteil, France
        • Recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Cécile Pautas
      • Dijon, France
        • Recruiting
        • Hopital Du Bocage
      • Le Chesnay, France
        • Recruiting
        • Hôpital André Mignot
        • Contact:
          • Juliette Lambert
      • Nantes, France
        • Recruiting
        • Hôpital Hotel Dieu
        • Contact:
          • Pierre PETERLIN
      • Orléans, France
        • Not yet recruiting
        • Hôpital de la Source
        • Contact:
          • Diana Carp
      • Paris, France
        • Not yet recruiting
        • Hôpital Saint Louis
        • Contact:
          • Emmanuel RAFFOUX
      • Pierre-Bénite, France
        • Recruiting
        • C.H. Lyon Sud
      • Vandoeuvre les nancy, France
        • Recruiting
        • Hôpital Brabois Adultes
        • Contact:
          • Caroline BONMATI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.
Time Frame: 2 years
2 years
Duration of second remission
Time Frame: 2 years
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).
Time Frame: 2 years
2 years
Cumulative incidence of early deaths
Time Frame: 60 days
60 days
Grade 3 to 5 liver, infectious and cardiac adverse events
Time Frame: 45 days
45 days
Severe adverse events during induction treatment
Time Frame: 45 days
45 days
Cumulative incidence of allogenic transplant among responder's patients with respects to age.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1612_MYLOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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