NCT00860639

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

9 years

First QC Date

March 11, 2009

Last Update Submit

January 26, 2017

Conditions

Acute Myeloid Leukemia

Keywords

AMLgemtuzumab ozogamycin

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (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.

    3 years

Study Arms (2)

gemtuzumab ozogamycin

ACTIVE COMPARATOR

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.

Drug: gemtuzumab ozogamycin

without Mylotarg

NO INTERVENTION

Interventions

gemtuzumab ozogamycinDRUG

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

Also known as: gemtuzumab ozogamycin (MYLOTARG ®)
gemtuzumab ozogamycin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

CH Pays d'Aix

Aix, France

Location

CHU Amiens

Amiens, France

Location

CHRU Angers

Angers, France

Location

CH Avignon

Avignon, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, France

Location

CHU Hôpital Minjoz

Besançon, France

Location

CHU Morvan

Brest, France

Location

CHU Hôtel Dieu

Clermont-Ferrand, France

Location

CH Louis Pasteur

Colmar, France

Location

CHU du Bocage

Dijon, France

Location

CHU Michallon

Grenoble, France

Location

CHU Dupuytren

Limoges, France

Location

Institut Paoli Calmette

Marseille, France

Location

CH Metz Thionvile

Metz, France

Location

CHU Lapeyronie

Montpellier, France

Location

CH Muller

Mulhouse, France

Location

CHU Hôtel Dieu

Nantes, France

Location

CHU Carémeau

Nîmes, France

Location

CH La Source

Orléans, France

Location

Hopital Cochin (AP-HP)

Paris, France

Location

CHU du Haut Lévèque

Pessac, France

Location

CHU Jean Bernard - La Milétrie

Poitiers, France

Location

CHU Robert Debré

Reims, France

Location

CHU Pontchaillou

Rennes, France

Location

Institut de Cancérologie de la Loire

Saint-Etienne, France

Location

CHU Hautepierre

Strasbourg, France

Location

CHU Purpan

Toulouse, France

Location

CHU Bretonneau

Tours, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jacques Delaunay, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

October 1, 2007

Primary Completion

September 26, 2016

Study Completion

September 26, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

FR(29)