ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
87 citing papers in PubMed, 1 synthesis or guideline pooled it, 120 citations in OpenAlex.
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia, version 2.0.Journal for immunotherapy of cancer · 2026Guideline
- Carfilzomib plus induction chemotherapy for children with relapsed or refractory acute lymphoblastic leukemia.Blood advances · 2026Trial
- Allogeneic HSCT outcomes and impact of defibrotide prophylaxis on SOS after inotuzumab in pediatric B-ALL.Blood advances · 2026Article
- Bridging therapy in pediatric and AYA patients under 25 years with relapsed/refractory B-ALL undergoing anti-CD19 CAR-T therapy: a multicenter retrospective study by the Spanish group GETH-TC.Bone marrow transplantation · 2026Article
- High-risk features in adult patients with B-cell acute lymphoblastic leukemia: redefining risk in the era of targeted immunotherapy.Blood research · 2026Review
- Hematopoietic cell transplantation after CD19-directed CAR T-cell therapy for remission consolidation or relapse treatment in pediatric acute lymphoblastic leukemia.Haematologica · 2026Article
- Incorporating Immunotherapies into the Evolving Standard of Care for Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia.Paediatric drugs · 2026Review
- B Cell Aplasia Following CAR T Cell Therapy: Incidence, Kinetics, Prognostic Implications, and Clinical Management.Cancers · 2026Review
- Advances in Oncohematology Immunotherapy: Monoclonal Antibodies and CAR T-Cell Therapies.Cells · 2026Review
- Global, regional, and national epidemiology of leukemia in children from 1990 to 2021: A cross-sectional study.Medicine · 2026Article
- Article
- Transplantation outcomes in patients with Down syndrome-associated acute lymphoblastic leukaemia: Implications for treatment intensity and the use of novel therapies.British journal of haematology · 2026Article
- Inotuzumab ozogamicin in individuals with Down syndrome and acute lymphoblastic leukemia.Leukemia · 2026Article
- CD19 CAR T-cell outcomes in relapsed/refractory extramedullary B-ALL: a multisite, retrospective cohort review.Blood advances · 2026Article
- Advances in targeted therapies for pediatric tumors.Acta pharmacologica Sinica · 2026Article
- Efficacy and safety of blinatumomab combination therapy in high-risk B-cell acute lymphoblastic leukemia: A systematic review and meta-analysis.Oncology letters · 2026Article
- [Evolving treatment landscape of pediatric acute leukemia: integration and breakthroughs in immunotherapy and targeted therapy].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026Review
- The quintessential role for CAR T cell therapy in children, adolescents and young adults with cancer.Nature reviews. Clinical oncology · 2026Review
- Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026Review
- Ten-year experience of CD22 CAR T cells for children and young adults with B-cell acute lymphoblastic leukemia.Blood advances · 2026Article
27 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 14 institutions in 1 country.
Funding
Abstract
purposeChildren's Oncology Group trial AALL1621 was conducted to prospectively determine the safety and efficacy of inotuzumab ozogamicin (InO) in pediatric and adolescent patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). PATIENTS AND
methodsThis single-arm phase II trial enrolled patients age 1-21 years with R/R CD22-positive B-ALL. In cycle 1, InO dosing was 0.8 mg/m
resultsForty-eight patients were evaluable for response and toxicity; 19 had complete response (CR) and nine CR with incomplete count recovery (CRi) after cycle 1 (CR/CRi rate: 58.3%; two-sided 90% CI, 46.5 to 69.3). Twenty-seven of 28 patients with CR or CRi had minimal residual disease measured by flow cytometry; 18 (66.7%) had minimal residual disease < 0.01%. Seven of 28 patients (25%) with CR or CRi had delayed count recovery past day 42 in cycle 1. Three (6.3%) patients had grade 3 ALT elevation and one patient had grade 3 hyperbilirubinemia in cycle 1. Of 21 patients undergoing hematopoietic stem-cell transplantation after InO, 6 (28.6%) developed grade 3 SOS. Partial CD22 expression and lower CD22 site density were associated with lower likelihood of response to InO.
conclusionInO is effective and well tolerated in heavily pretreated children and adolescents with R/R CD22-positive B-ALL. SOS after hematopoietic stem-cell transplantation and prolonged cytopenias were notable. CD22 modulation was identified as a mechanism of resistance. Expanded study of InO combined with chemotherapy is underway.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.