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

• Status: Completed
• Trial end date: 2016-09-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborators: Chugai Pharmaceutical; French Innovative Leukemia Organisation
• Treatments: Gemtuzumab

Criteria

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- 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