Objective: This study aims to evaluate patient-reported quality of life (QoL) in children with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who received first-line treatment with blinatumomab in the CCLG-ALL 2018 supplementary study (ChiCTR2400083570).

Methods: CCLG-ALL 2018 supplementary study evaluated the outcomes of blinatumomab in combination with chemotherapy for intermediate risk (MR) and high risk (HR) patients.MR patients received 14 days of blinatumomab (replacing induction) after a 15-day chemotherapy induction, while HR patients received 28 days of blinatumomab (replacing induction/early intensification block 1), followed by early intensification and consolidation chemotherapy. QoL was measured with the Pediatric Quality of Life Inventory (PedsQL) 3.0 cancer module. Child self-report was used for patients aged 5–18 years and parent proxy-report for patients aged 2–18 years. Patients who received blinatumomab and their parents would complete the questionnaires at baseline (after 15 days of chemotherapy induction), during or after blinatumomab treatment (d33), after early intensification block 1 (d45), and after early intensification (d60). We also collected QoL from the patients who received only chemotherapy during the same period at the same time points. The PedsQL 3.0 cancer module consists of Pain and hurt, Nausea, Procedural anxiety, Treatment anxiety, Worry, Cognitive problems, Perceived physical appearance, Communication subscale scores, and a total score (sum of all the items over the number of items answered on all the scales). All PedsQL scores range from 0 to 100, with higher scores indicating better QoL.

Results: From November 2024 to July 2025, 73 patients aged 2–18 years were included in the analysis, with 54 patients having an assessment at baseline and at least one postbaseline visit. There were 29 patients in the blinatumomab group and 25 in the chemotherapy group. The median age in the blinatumomab group was 5 years (range 2-15), with 4 HR and 25 MR cases, and 18 patients receiving outpatient blinatumomab infusions. The median age in the chemotherapy-only group was 7 years (range 2-14), with 15 standard-risk and 10 MR cases. In the child self-report, the blinatumomab group showed improvements in PedsQL total scores with mean changing from baseline to d33, d45, and d60 of +10.15, +5.63, and +2.53. Due to subsequent chemotherapy, mean changes of total scores from baseline to d45 and d60 decreased. The greatest improvements were observed in mean changes from baseline to d33 for Pain and Hurt (+17.31), Nausea (+11.88), Worry (+6.25), Cognitive problems (+20.19), Perceived Physical Appearance (+31.25), and Communication (+12.5). The chemotherapy group showed minor changes from baseline to d33, d45 of +0.27, +5.53 and decreased by -5.29 in d60, respectively, with deterioration in Nausea (-10.71) after induction therapy.

Similar trends were observed in parent proxy-report, with the blinatumomab group showing mean changes from baseline to d33, d45, and d60 of +9.59, +5.93, and +3.85. The greatest improvements were observed in mean changes from baseline to d33 for Pain and Hurt (+8.21), Nausea (+6.82), Procedural Anxiety (+8.39), Treatment Anxiety (+16.67), Worry (+17.16), Perceived Physical Appearance (+10.29), and Communication (+11.27). The chemotherapy group showed mean changes from baseline to d33, d45, and d60 of -2.83, +2, and -0.88, respectively, with deterioration in Nausea (-10.72), Perceived Physical Appearance (-9.26), and Communication (-11.27) after induction therapy.

Conclusion: Preliminary analysis found that QoL deteriorated after continued chemotherapy induction, particularly in terms of Nausea, Perceived physical appearance, and Communication. However, substituting part of the induction or early intensification chemotherapy with blinatumomab significantly improves QoL, with notable increases in multiple terms. This suggests that blinatumomab can enhance patients' QoL compared to chemotherapy. The study is ongoing, and more patients will be enrolled.

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2025
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