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Acute Myeloid LeukemiaPhase 3LAM2006IRNCT00860639

Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk

A Phase 3 study testing gemtuzumab ozogamycin in people with Acute Myeloid Leukemia, run by Nantes University Hospital at 29 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
gemtuzumab ozogamycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
327 participants
Where
29 sitesFrance
Study dates
Oct 2007to 26 Sep 2016
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients with de novo AML and intermediate risk as defined by the cytogenetics criteria of GOELAMS Group:
  • Normal karyotype or
  • Karyotype with other abnormalities, excluding the favourable group [t (15; 17), t (8; 21), inv (16)] and the high risk group [(-5/5q-, -7/7q- , t (9.22), t (6.9), 11q23 anomaly excluding the t (9; 11), abnormal 3q, complex karyotype (> 3 abnormalities)]. Not previously treated for AML.
  • Patients aged 18 to 60 years
  • And having more than 20% of blast cells in bone marrow and as previously described.
  • And with intermediate cytogenetics as previously defined
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  • And whose expression of the CD33 antigen on the blasts was defined using standard method
  • And with a WBC <or equal to 100G/L.
  • And who can receive either one or the other of the treatments under study
  • And having a good performance status (WHO score <3) with a life expectancy greater than one month.
  • Affiliated with the Social Security

Who cannot join

  • Patients aged under 18 or over 60 years
  • OR with AML:
  • Not classifiable in the classification French-American-British (FAB)
  • Type M3
  • Or blastic transformation of a myeloproliferative or myelodysplastic syndrome previously diagnosed
  • Outside the intermediate cytogenetic group as previously defined
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  • OR with isolated extramedullary localization of their disease
  • OR WBC> 100G / L
  • Patients with known human immunodeficiency virus (HIV) infection or human T-lymphotrophic virus 1 (HTLV-1)
  • Patients with SGOT/SGPT >5N
  • Patients with a calculated creatinine clearance of <50 mL/min
  • Informed consent refusal
  • Pregnant and/or lactating female

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • CH Pays d'Aix

    Aix

  • CHU Amiens

    Amiens

  • CHRU Angers

    Angers

  • CH Avignon

    Avignon

  • Centre Hospitalier de la Côte Basque

    Bayonne

  • CHU Hôpital Minjoz

    Besançon

  • CHU Morvan

    Brest

  • CHU Hôtel Dieu

    Clermont-Ferrand

  • CH Louis Pasteur

    Colmar

  • CHU du Bocage

    Dijon

  • CHU Michallon

    Grenoble

  • CHU Dupuytren

    Limoges

  • Institut Paoli Calmette

    Marseille

  • CH Metz Thionvile

    Metz

  • CHU Lapeyronie

    Montpellier

  • CH Muller

    Mulhouse

  • CHU Hôtel Dieu

    Nantes

  • CHU Carémeau

    Nîmes

  • CH La Source

    Orléans

  • Hopital Cochin (AP-HP)

    Paris

  • CHU du Haut Lévèque

    Pessac

  • CHU Jean Bernard - La Milétrie

    Poitiers

  • CHU Robert Debré

    Reims

  • CHU Pontchaillou

    Rennes

  • Institut de Cancérologie de la Loire

    Saint-Etienne

  • CHU Hautepierre

    Strasbourg

  • CHU Purpan

    Toulouse

  • CHU Bretonneau

    Tours

  • CHU Brabois

    Vandœuvre-lès-Nancy

Other trials in France

About this study

Official title: Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk

The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.

Read the detailed description

Initial randomization will be completed upon receipt of karyotype results and will determine the administration of gemtuzumab ozogamycin (MYLOTARG ®) in combination with chemotherapy during the induction course and the first intensive consolidation course. The induction course include: Daunorubicin for 3 days (60mg/m²) associated with cytarabine (200mg/m²) for 7 days. The MYLOTARG ® will be administered according to the randomization arm on the 4th day of treatment by slow intravenous infusion of 2 hours at a dose of 6 mg/m2. Early bone marrow assessment will be performed at D15. In case of blast excess (>5%) , a second course of induction will be administered.

The consolidation treatment depends on age, molecular prognostic factors, and donor availability:

  • Patients with good molecular prognosis profile [ NPM1 + / FLT3 ITD - or CEBPa mutated ] will be consolidated by two courses of intensive chemotherapy comprising Mitoxanthrone and intermediate dose of Cytarabine with or without MYLOTARG ® according to the initial randomization during the first course.
  • Patients younger than 51 years, eligible for standard allogeneic transplantation with sibling or full matched unrelated donor will receive a standard bone marrow transplantation which not begin before 90 days after the induction.
  • Patients with no donor or older than 50 years, or with a donor being identified, will receive two courses of intensive consolidation comprising Mitoxantrone and intermediate-dose of Cytarabine with or without Mylotarg ® 6 mg / m² during the first consolidation according to the randomisation arm.
  • Patients aged 51 to 60 years with an HLA identical donor (sibling or unrelated), will receive a non-myeloablative haematopoietic stem cells transplant (HSCT) after the second course of consolidation.
  • For other patients, an autologous hematopoietic stem cells transplant (HSCT) will be performed after the 2nd course of consolidation. Collection of peripheral blood stem cells (PBSCs) will be performed after the first consolidation course and a second collection may be considered after the second consolidation course in case of inadequate collection.
Being tested
gemtuzumab ozogamycin
Keywords
AML, gemtuzumab ozogamycin
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 ozogamycinDrug

    Also called gemtuzumab ozogamycin (MYLOTARG ®)

    gemtuzumab ozogamycin = 6mg/m² during the induction course (Day 4) gemtuzumab ozogamycin = 6mg/m² during the first intensive consolidation course (Day 4)

Study groups in NCT00860639
Study groupRoleWhat they receive
gemtuzumab ozogamycinActive comparatorInitial randomization will be completed upon receipt of karyotype results and will determine the administration of gemtuzumab ozogamycin (MYLOTARG ®) in combination with chemotherapy during the induction course and the first intensive consolidation course.
Receives: Drug: gemtuzumab ozogamycin
without MylotargNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation

    Measured: 3 years

Secondary outcomes (1)

  1. Complete Remission Rate (CR) Overall Survival at 3 years Relapse rate at 3 years Toxicity and tolerability of each treatment arm Evaluation of Minimal residual disease by WT1 and NPM1 study at different phases of treatment.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study startOct 2007
  3. Primary completion26 Sep 2016
  4. Study completion26 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860639
Sponsor's protocol ID
BRD/06/10-I
Acronym
LAM2006IR
Status last verified
Jan 2017
First submitted
11 Mar 2009
Last updated
27 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemtuzumab ozogamycin in people with Acute Myeloid Leukemia, run by Nantes University Hospital at 29 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860639.

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 27 Jan 2017.

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