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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acute Leukemia French Association
• Treatments: Cytarabine; Gemtuzumab

Criteria

Inclusion Criteria:

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

1. Age ≥ 50 years and ≤ 70 years.

2. First relapsing AML with a duration of first CR ≥ 3 and ≤18 months

3. ECOG performance status 0 to 3

4. Negative serology HIV, HBV and HBC (except post vaccination)

5. Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N

6. Cardiac function determined by radionuclide or echography within normal limits.

7. Negative serum pregnancy test within one week before treatment for women of child bearing potential

8. Signed informed consent.

Exclusion Criteria:

1. M3-AML

2. AML following diagnosed myelodysplastic syndrome or myeloproliferation

3. Known central nervous system involvement with AML

4. Prior treatment with HSCT.

5. Previous treatment with Anti CD33 antibodies

6. Uncontrolled infection

7. Other active malignancy