Working… Menu
Trial record 12 of 91 for:    gemtuzumab ozogamicin

Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk (LAM2006IR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860639
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : January 27, 2017
Chugai Pharmaceutical
French Innovative Leukemia Organisation
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: gemtuzumab ozogamycin Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

Arm Intervention/treatment
Active Comparator: gemtuzumab ozogamycin
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
gemtuzumab ozogamycin = 6mg/m² during the induction course (Day 4) gemtuzumab ozogamycin = 6mg/m² during the first intensive consolidation course (Day 4)
Other Name: gemtuzumab ozogamycin (MYLOTARG ®)

No Intervention: without Mylotarg

Primary Outcome Measures :
  1. event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT00860639

Layout table for location information
CH Pays d'Aix
Aix, France
CHU Amiens
Amiens, France
CHRU Angers
Angers, France
CH Avignon
Avignon, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHU Hôpital Minjoz
Besancon, France
CHU Morvan
Brest, France
CHU Hôtel Dieu
Clermont-Ferrand, France
CH Louis Pasteur
Colmar, France
CHU du Bocage
Dijon, France
CHU Michallon
Grenoble, France
CHU Dupuytren
Limoges, France
Institut Paoli Calmette
Marseille, France
CH Metz Thionvile
Metz, France
CHU Lapeyronie
Montpellier, France
CH Muller
Mulhouse, France
CHU Hôtel Dieu
Nantes, France
CHU Carémeau
Nimes, France
CH La Source
Orléans, France
Hopital Cochin (AP-HP)
Paris, France
CHU du Haut Lévèque
Pessac, France
CHU Jean Bernard - La Milétrie
Poitiers, France
CHU Robert Debré
Reims, France
CHU Pontchaillou
Rennes, France
Institut de Cancérologie de la Loire
Saint Etienne, France
CHU Hautepierre
Strasbourg, France
CHU Purpan
Toulouse, France
CHU Bretonneau
Tours, France
CHU Brabois
Vandoeuvre Les Nancy, France
Sponsors and Collaborators
Nantes University Hospital
Chugai Pharmaceutical
French Innovative Leukemia Organisation
Layout table for investigator information
Principal Investigator: Jacques Delaunay, MD Nantes University Hospital

Layout table for additonal information
Responsible Party: Nantes University Hospital Identifier: NCT00860639     History of Changes
Other Study ID Numbers: BRD/06/10-I
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Keywords provided by Nantes University Hospital:
gemtuzumab ozogamycin
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents