DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

Induction course are:

GO 3mg/m2 on days 1, 4,7 + the three dose levels were as follows:

level 1: DNR: 45 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 2: DNR: 60 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 3: DNR 60 mg/m2 x 3 days + AraC: 200 mg/m2 x 7 days. with 20 mg of methylprednisolone prior to each GO infusion. Consolidation course: patients in CR may receive 2 additional courses of consolidation chemotherapy with Amsacrine 90 mg/m2 daily for 3 days, and Ara-C (1g/m2/12 hours x 3 days) + GO 3 mg/m2 on day 1.

Treatment with HSCT is offered at the discretion of the physician in charge of the patient. A delay between last infusion of GO and HSCT above 3 months is recommended

Inclusion criteria

Patients with a morphologically proven diagnosis of CD33-positive AML and :

• Age ≥ 50 years and ≤ 70 years.
• First relapsing AML with a duration of first CR ≥ 3 and ≤18 months
• ECOG performance status 0 to 3
• Negative serology HIV, HBV and HBC (except post vaccination)
• Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N
• Cardiac function determined by radionuclide or echography within normal limits.
• Negative serum pregnancy test within one week before treatment for women of child bearing potential
• Signed informed consent.

Exclusion criteria

• M3-AML
• AML following diagnosed myelodysplastic syndrome or myeloproliferation
• Known central nervous system involvement with AML
• Prior treatment with HSCT.
• Previous treatment with Anti CD33 antibodies
• Uncontrolled infection
• Other active malignancy