Leukemia, Myeloid, AcuteMYLORNCT03287128
Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®
An observational study of Leukemia, Myeloid, Acute, run by Versailles Hospital at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Gemtuzumab Ozogamicin (GO)
- How many people
- 300 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Nov 2017to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Previous treatment with GO
- AML type 3
- More than 1 relapse
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
C.H.U. d'Amiens - Hôpital Sud
Amiens
Magalie JORIS
- Recruiting
C.H.U. d'Angers
Angers
Mathilde HUNAULT
- Recruiting
HIA Percy
Clamart
Jean Valère MALFUSON
- Recruiting
Hôpital Henri Mondor
Créteil
Cécile PAUTAS
- Recruiting
Hôpital du Bocage
Dijon
Denis CAILLOT
- Recruiting
Hôpital André Mignot
Le Chesnay
Juliette LAMBERT
- Recruiting
Hôpital Hotel Dieu
Nantes
Pierre PETERLIN
- Not yet recruiting
Hôpital de la Source
Orléans
Diana CARP
- Not yet recruiting
Hopital Saint Louis
Paris
Emmanuel RAFFOUX
- Recruiting
C.H. Lyon Sud
Pierre-Bénite
Xavier THOMAS
- Recruiting
Hôpital Brabois Adultes
Vandœuvre-lès-Nancy
Caroline BONMATI
About this study
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®
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.
Read more
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
- Being tested
- Gemtuzumab Ozogamicin (GO)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemtuzumab Ozogamicin (GO)Drug
patients included in a compassionate patient named program with GO
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Measured: 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.
Measured: 2 years
Duration of second remission
Measured: 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).
Measured: 2 years
Cumulative incidence of early deaths
Measured: 60 days
Grade 3 to 5 liver, infectious and cardiac adverse events
Measured: 45 days
Severe adverse events during induction treatment
Measured: 45 days
Cumulative incidence of allogenic transplant among responder's patients with respects to age.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Nov 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ms Juliette LAMBERT, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287128
- Sponsor's protocol ID
- P1612_MYLOR
- Acronym
- MYLOR
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT03287128
- Acronym / sponsor ID
- MYLOR / P1612_MYLOR
- Conditions
- Leukemia, Myeloid, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous treatment with GO
- AML type 3
- More than 1 relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemtuzumab Ozogamicin (GO)patients included in a compassionate patient named program with GO | Drug | – |
Primary outcome
Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Time frame: 45 days
7 secondary outcomes
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
Duration of second remission
Time frame: 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
Cumulative incidence of early deaths
Time frame: 60 days
Grade 3 to 5 liver, infectious and cardiac adverse events
Time frame: 45 days
Severe adverse events during induction treatment
Time frame: 45 days
Cumulative incidence of allogenic transplant among responder's patients with respects to age.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute, run by Versailles Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure MORISSET (+33-1-39-23-97-85, lmorisset@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi). (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.