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. 2018 Nov 29;2(6):e159.
doi: 10.1097/HS9.0000000000000159. eCollection 2018 Dec.

Maintenance Therapy With Interleukin-2 for Childhood AML: Results of ELAM02 Phase III Randomized Trial

Arnaud Petit  1 , Stéphane Ducassou  2 , Thierry Leblanc  3 , Marlène Pasquet  4 , Alexandra Rousseau  5 , Christine Ragu  1 , Marine Cachanado  5 , Brigitte Nelken  6 , Yves Bertrand  7 , Gérard Michel  8 , Virginie Gandemer  9 , Wendy Cuccuini  10 , Odile Fenneteau  11 , Hélène Lapillonne  12 , Anne Auvrignon  1 , André Baruchel  3 , Guy Leverger  1
Affiliations

Maintenance Therapy With Interleukin-2 for Childhood AML: Results of ELAM02 Phase III Randomized Trial

Arnaud Petit et al. Hemasphere. .

Abstract

Despite significant progress in the treatment of pediatric acute myeloblastic leukemia (AML), relapse remains the commonest cause of death. Randomized ELAM02 trial questioned if maintenance therapy with interleukin-2 (IL2), for 1 year, improves disease-free survival (DFS). Patients aged 0 to 18 years, with newly diagnosed AML (excluding patients with acute promyelocytic leukemia or down syndrome AML) were enrolled. They received 1 course of induction treatment (cytarabine and mitoxantrone) and 3 courses of consolidation treatment (high-dose cytarabine in courses 1 and 3). According to the cytogenetics risk, patients not undergoing hematopoietic stem cell transplantation, still in complete remission (CR) after the third course of consolidation treatment, were eligible for randomization to 1 year of maintenance therapy with monthly courses of IL2 or no maintenance treatment. There were 438 evaluable patients, 154 of whom were randomized to the IL2/no maintenance groups. Relapse occurred in 28 patients from the IL2+ group and 29 patients in the IL2- group. Survival was similar in the 2 groups, with a 4-year DFS of 62% without IL2 and 66% with IL2 (P = 0.75). In the CBF population, 4-year DFS was 55% without IL2 and 78% with IL2 (P = 0.07). No deaths from toxicity or excess of serious adverse events related to IL2 treatment were recorded. Prolonged IL2 for maintenance therapy after intensive chemotherapy is feasible and safe in pediatric AML patients in their first CR. Such treatment did not improve DFS in this study, but a positive trend was observed in favor of IL2 maintenance therapy among core binding factor acute myeloblastic leukemia.

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Figures

Figure 1
Figure 1
Treatment scheme for the ELAM02 trial. abn = abnormality, CR = complete remission, d = day, HSCT = hematopoietic stem cell transplantation, R = randomization.
Figure 2
Figure 2
Flowchart.
Figure 3
Figure 3
Comparison of disease-free survival between IL2− and IL2+ patients.
Figure 4
Figure 4
Comparison of overall survival between IL2− and IL2+ patients.
Figure 5
Figure 5
Comparison of disease-free survival between IL2− and IL2+ patients among CBF AML. CBF AML = core binding factor acute myeloblastic leukemia.
See this image and copyright information in PMC

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