What question did this study set out to answer?

Evaluate the effectiveness of fludarabine compared to high dose cytarabine in standard risk pediatric AML.

December 8, 2025BloodOpen Access

Fludarabine and cytarabine is not superior to high dose cytarabine as consolidation therapy in standard risk AML in children: Results from the international Phase III MyeChild01 trial

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International trial finds no superiority of fludarabine over high dose cytarabine for AML consolidation, highlighting genetic factors.

Evaluate the effectiveness of fludarabine compared to high dose cytarabine in standard risk pediatric AML.
Phase III trial with 360 patients randomised to fludarabine or high dose cytarabine for consolidation therapy.
Treatment stratified by genetic subtype, remission status, and measurable residual disease.
Bayesian statistical analysis with relapse-free survival as the primary outcome.
2-year relapse-free survival was 78% for high dose cytarabine vs 70% for fludarabine.
Overall survival was 97% for high dose cytarabine vs 90% for fludarabine.
Cumulative incidence of relapse was 22% for high dose cytarabine vs 29% for fludarabine, indicating no significant difference.

Smith et al. (2025) studied this question.

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