Clinical trial · Interventional
Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2
Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2
NCT00149162CI-TRIAL-00002045Elam02unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proleukin | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Patients treated by Proleukin
- interventionNames
- Drug: proleukin
- type
- NO_INTERVENTION
- label
- 2
- description
- Without Proleukin
Primary outcomes (1)
- measure
- Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
- timeFrame
- 1 year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * Trisomy 21 * Promyelocytic leukemia (M3) or M3 variations * Secondary AML
References
Publications (19)
- BACKGROUNDLie SO, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Gustafsson G. A population-based study of 272 children with acute myeloid leukaemia treated on two consecutive protocols with different intensity: best outcome in girls, infants, and children with Down's syndrome. Nordic Society of Paediatric Haematology and Oncology (NOPHO). Br J Haematol. 1996 Jul;94(1):82-8. doi: 10.1046/j.1365-2141.1996.d01-1761.x. PMID 8757513
- BACKGROUNDWells RJ, Woods WG, Buckley JD, Odom LF, Benjamin D, Bernstein I, Betcher D, Feig S, Kim T, Ruymann F, et al. Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study. J Clin Oncol. 1994 Nov;12(11):2367-77. doi: 10.1200/JCO.1994.12.11.2367. PMID 7964952
- BACKGROUNDLipshultz SE, Colan SD, Gelber RD, Perez-Atayde AR, Sallan SE, Sanders SP. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med. 1991 Mar 21;324(12):808-15. doi: 10.1056/NEJM199103213241205. PMID 1997853
- BACKGROUNDMertens AC, Wen W, Davies SM, Steinbuch M, Buckley JD, Potter JD, Robison LL. Congenital abnormalities in children with acute leukemia: a report from the Children's Cancer Group. J Pediatr. 1998 Nov;133(5):617-23. doi: 10.1016/s0022-3476(98)70100-3. PMID 9821417
- BACKGROUNDKrischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. doi: 10.1200/JCO.1997.15.4.1544. PMID 9193351
- BACKGROUNDBehar C, Suciu S, Benoit Y, Robert A, Vilmer E, Boutard P, Bertrand Y, Lutz P, Ferster A, Tokaji E, Manel AM, Solbu G, Otten J. Mitoxantrone-containing regimen for treatment of childhood acute leukemia (AML) and analysis of prognostic factors: results of the EORTC Children Leukemia Cooperative Study 58872. Med Pediatr Oncol. 1996 Mar;26(3):173-9. doi: 10.1002/(SICI)1096-911X(199603)26:33.0.CO;2-H.