Status:
UNKNOWN
Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Chiron Corporation
Conditions:
Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction an...
Detailed Description
We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after indu...
Eligibility Criteria
Inclusion
- Age: 0 to 18 years
- Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts \> 20 %)
- Isolated myeloid sarcoma
- Achieved complete remission
- No HLA identical family donor, except for the patients with t(8;21)
- No contraindication for the use of interleukin-2
Exclusion
- Trisomy 21
- Promyelocytic leukemia (M3) or M3 variations
- Secondary AML
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00149162
Start Date
March 1 2005
End Date
March 1 2012
Last Update
February 12 2009
Active Locations (1)
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1
Children Armand Trousseau Hospital
Paris, France