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DELPHINUS: Daratumumab plus chemotherapy in pediatric patients with R/R ALL or LL
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The phase II DELPHINUS trial (NCT03384654) assessed the safety and efficacy of daratumumab, an anti-CD38 monoclonal antibody, plus backbone chemotherapy in pediatric patients with B-cell ALL after ≥2 relapses (n = 7), and in pediatric and young adult patients with T-cell ALL (pediatric, n = 24; young adult, n = 5) and LL (n = 10) in first relapse.1 Results from this trial were published in Blood by Bhatla et al.1 |
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CR rates after Cycle 2 in the pediatric T-cell ALL, young adult T-cell ALL, and T-cell LL cohorts were 50%, 60.0%, and 40%, respectively, with overall response rates of 83.3%, 80.0%, and 50.0%. No patients in the B-cell ALL cohort achieved a CR and the cohort was closed due to futility. |
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In the pediatric T-cell ALL, young adult T-cell ALL, and T-cell LL cohorts, the observed 24-month EFS rates were 36.1%, 20.0%, and 20.0%, the observed 24-month OS rates were 41.3%, 25.0%, and 20.0%, and allo-HSCT rates were 75.0%, 60.0%, and 30.0%, respectively. |
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The combination treatment was well tolerated, with no new safety concerns observed, aligning with known daratumumab safety profiles in adult patients with R/R multiple myeloma. |
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Daratumumab combined with chemotherapy demonstrates potential in pediatric and young adult patients with R/R T-cell ALL and LL, showing encouraging response rates and serving as a bridge to allo-HSCT. Although daratumumab did not show efficacy in patients with B-cell ALL, the results support its role in R/R T-cell ALL/LL. |
Abbreviations: ALL, acute lymphoblastic leukemia; allo-HSCT, allogeneic hematopoietic stem cell transplant; CR, complete response; EFS, event-free survival; LL, lymphoblastic lymphoma; OS, overall survival; R/R, relapsed/refractory.
- Bhatla T, Hogan L, Teachey DT, et al. Daratumumab in pediatric relapsed/refractory acute lymphoblastic leukemia or lymphoblastic lymphoma: DELPHINUS study. Blood. 2024. Online ahead of print. DOI: 1182/blood.2024024493
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