Informations générales (source: ClinicalTrials.gov)

NCT00149162 Statut inconnu
Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2 (Elam02)
Interventional
  • Leucémies
  • Leucémie aigüe myéloïde
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2005
mars 2012
29 juin 2024
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 and consolidation chemotherapy concerning the event free survival.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
EFS IDF SITE ARMAND TROUSSEAU Anne Auvrignon, M.D. En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- 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



- Trisomy 21

- Promyelocytic leukemia (M3) or M3 variations

- Secondary AML