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Acute lymphocytic leukemia (ALL) is the most common malignant disease in children .
Children Western Europe has 40 new ALL cases per million children under 15 each year
However, the prognosis of such children (about 15%) who are refractory to conventional treatment after recurrence or conventional treatment is still relatively poor .
After recurrence or refractory to conventional treatment, the prognosis of these children (about 15%) is still poor.
Inotuzumab ozogamicin (InO) is a new type of CD22 targeting antibody-drug conjugate FDA
This study is a phase 1 trial to study the efficacy and safety of the recommended phase 2 dose of InO (RP2D) in children with multiple relapse/refractory (R/R) CD22+ ALL .
To study the efficacy and safety of the recommended phase 2 dose of InO (RP2D) in children with multiple relapse/refractory (R/R) CD22+ ALL
Children (1-18 years old) were given 3 doses of InO (day 1, 8 and 15) per course of treatment.
The most common adverse events
The most common adverse eventsA total of 25 children were recruited (23 children can be assessed for DLT).
In the first course of treatment, 1 out of 6 children in DL1 and 2 out of 5 children in DL2 in the first cohort experienced DLT
Duration of relief
Duration of reliefGrade 3-4 adverse events occurred in 23 patients ; after subsequent chemotherapy, 2 patients reported sinusoidal obstruction syndrome.
The overall response rate after the first course of treatment for 23 patients with grade 3-4 adverse events was 80% (20/25; DL1: 75%, DL2: 85%).
PFS and OS of the general population
PFS and OS of the general populationAfter InO, 9 children received hematopoietic stem cell transplantation or chimeric antigen recipient T cell transplantation.
After InO, 9 children received hematopoietic stem cell transplantation or chimeric antigen recipient T cell transplantation.
InO is well tolerated in children with pretreated CD22+ R/R ALL and exhibits certain anti-leukemia activity.
Original source:
Erica Brivio, et al.
org/10.
1182/blood.
2020007848" target="_blank" rel="noopener">A phase 1 study of inotuzumab ozogamicin in pediatric relapsed / refractory acute lymphoblastic leukemia (ITCC-059 study) in this message
