Acute Myeloid Leukemia Clinical Trial
— LAM2006IROfficial 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
Verified date | January 2017 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 327 |
Est. completion date | September 26, 2016 |
Est. primary completion date | September 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital | Chugai Pharmaceutical, French Innovative Leukemia Organisation |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation | 3 years | ||
Secondary | 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 |
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