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

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ClinicalTrials.gov Identifier: NCT03287128
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ms Juliette LAMBERT, Versailles Hospital

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.


Condition or disease Intervention/treatment
Leukemia, Myeloid, Acute Drug: Gemtuzumab Ozogamicin (GO)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
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®
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : March 1, 2019



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


Primary Outcome Measures :
  1. Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi). [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. 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. Duration of second remission [ Time Frame: 2 years ]
  3. 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 ]
  4. Cumulative incidence of early deaths [ Time Frame: 60 days ]
  5. Grade 3 to 5 liver, infectious and cardiac adverse events [ Time Frame: 45 days ]
  6. Severe adverse events during induction treatment [ Time Frame: 45 days ]
  7. Cumulative incidence of allogenic transplant among responder's patients with respects to age. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287128


Contacts
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Contact: Laure MORISSET +33-1-39-23-97-85 lmorisset@ch-versailles.fr

Locations
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France
C.H.U. d'Amiens - Hôpital Sud Recruiting
Amiens, France
Contact: Magalie JORIS         
C.H.U. d'Angers Recruiting
Angers, France
Contact: Mathilde HUNAULT         
HIA Percy Recruiting
Clamart, France
Contact: Jean Valère MALFUSON         
Hôpital Henri Mondor Recruiting
Créteil, France
Contact: Cécile PAUTAS         
Hôpital du Bocage Recruiting
Dijon, France
Contact: Denis CAILLOT         
Hôpital André Mignot Recruiting
Le Chesnay, France
Contact: Juliette LAMBERT         
Hôpital Hotel Dieu Recruiting
Nantes, France
Contact: Pierre PETERLIN         
Hôpital de la Source Not yet recruiting
Orléans, France
Contact: Diana CARP         
Hopital Saint Louis Not yet recruiting
Paris, France
Contact: Emmanuel RAFFOUX         
C.H. Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Xavier THOMAS         
Hôpital Brabois Adultes Recruiting
Vandoeuvre les nancy, France
Contact: Caroline BONMATI         
Sponsors and Collaborators
Versailles Hospital

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Responsible Party: Ms Juliette LAMBERT, study Coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03287128     History of Changes
Other Study ID Numbers: P1612_MYLOR
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents