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Murine Model of Leukemia Relapse to Induction Chemotherapy for Acute Lymphoblastic Leukemia
Published on: October 17, 2025
Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol:
Rob Pieters1,2, Paola De Lorenzo3, Philip Ancliffe4
1Dutch Childhood Oncology Group, Utrecht, the Netherlands.
Insights
Myeloid consolidation chemotherapy did not improve outcomes for infant acute lymphoblastic leukemia (ALL). The Interfant-06 study found KMT2A rearrangement to be the strongest prognostic factor for event-free survival in infant ALL.
Area of Science:
- Pediatric Oncology
- Hematology
- Genetics
Background:
- Infant acute lymphoblastic leukemia (ALL) is characterized by KMT2A (MLL) gene rearrangements and myeloid marker coexpression.
- The Interfant-06 study aimed to improve treatment strategies for infant ALL.
Purpose of the Study:
- To determine if myeloid-style consolidation chemotherapy is superior to lymphoid-style chemotherapy in infant ALL.
- To evaluate the role of stem-cell transplantation (SCT) in infant ALL.
- To identify independent prognostic factors for infant ALL outcomes.
Main Methods:
- The Interfant-06 study included 651 infants diagnosed with ALL.
- Patients were stratified into low, medium, and high-risk groups based on KMT2A status, age, WBC count, and prednisone response.
- Randomized assignment to lymphoid (IB) or myeloid (ADE/MAE) consolidation chemotherapy was performed for medium and high-risk groups.
Main Results:
- 6-year event-free survival (EFS) and overall survival were 46.1% and 58.2%, respectively.
- Myeloid consolidation chemotherapy (ADE/MAE) did not significantly improve disease-free survival compared to lymphoid chemotherapy (IB).
- KMT2A rearrangement was the strongest prognostic factor for EFS, followed by age, WBC count, and prednisone response.
Conclusions:
- Early intensification with postinduction myeloid-type chemotherapy did not improve outcomes for infant ALL compared to the lymphoid-type course.
- Outcomes for infant ALL in the Interfant-06 study did not show improvement compared to the previous Interfant-99 study.
Purpose:
Infant acute lymphoblastic leukemia (ALL) is characterized by KMT2A (MLL) gene rearrangements and coexpression of myeloid markers. The Interfant-06 study, comprising 18 national and international study groups, tested whether myeloid-style consolidation chemotherapy is superior to lymphoid style, the role of stem-cell transplantation (SCT), and which factors had independent prognostic value.
Materials And Methods:
Three risk groups were defined: low risk (LR): KMT2A germline; high risk (HR): KMT2A-rearranged and older than 6 months with WBC count 300 × 109/L or more or a poor prednisone response; and medium risk (MR): all other KMT2A-rearranged cases. Patients in the MR and HR groups were randomly assigned to receive the lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE).
Results:
A total of 651 infants were included, with 6-year event-free survival (EFS) and overall survival of 46.1% (SE, 2.1) and 58.2% (SE, 2.0). In West European/North American groups, 6-year EFS and overall survival were 49.4% (SE, 2.5) and 62.1% (SE, 2.4), which were 10% to 12% higher than in other countries. The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P = .47). The 6-year EFS rate of patients in the HR group was 20.9% (SE, 3.4) with the intention to undergo SCT; only 46% of them received SCT, because many had early events. KMT2A rearrangement was the strongest prognostic factor for EFS, followed by age, WBC count, and prednisone response.
Conclusion:
Early intensification with postinduction myeloid-type chemotherapy courses did not significantly improve outcome for infant ALL compared with the lymphoid-type course IB. Outcome for infant ALL in Interfant-06 did not improve compared with that in Interfant-99.
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