Status:
COMPLETED
Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Chugai Pharmaceutical
French Innovative Leukemia Organisation
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 th...
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 induct...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2016
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT00860639
Start Date
October 1 2007
End Date
September 26 2016
Last Update
January 27 2017
Active Locations (29)
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1
CH Pays d'Aix
Aix, France
2
CHU Amiens
Amiens, France
3
CHRU Angers
Angers, France
4
CH Avignon
Avignon, France