{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T04:54:51Z","timestamp":1767156891759,"version":"3.44.0"},"reference-count":13,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T00:00:00Z","timestamp":1757462400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"Introduction<\/jats:title>The treatment of B-cell acute lymphoblastic leukemia (ALL) in India involves multi-agent chemotherapy and central nervous system (CNS) prophylaxis, but relapsed\/refractory (R\/R) B-cell ALL presents with high mortality and limited salvage options. Inotuzumab ozogamicin (InO), a monoclonal antibody targeting cluster of differentiation-22 (CD22) conjugated to calicheamicin, has improved outcomes for R\/R B-cell ALL. A phase 3 multicenter trial (INO-VATE) in adult patients with CD22+ B-cell ALL has shown that InO significantly increases response rates and overall survival (OS) compared to standard treatments, with ongoing studies assessing its real-world effectiveness in India.<\/jats:p><\/jats:sec>Methodology<\/jats:title>A multicentric, retrospective, observational study was conducted across five oncology centers in India to evaluate the effectiveness of InO in adult patients with R\/R B-cell ALL. The study aimed to assess clinical outcomes, including the rate of complete remission (CR)\/CR with incomplete hematologic recovery (CRi), minimal residual disease (MRD) negativity, duration of remission (DOR), OS, and the safety and tolerability of InO in real-world settings.<\/jats:p><\/jats:sec>Results<\/jats:title>The medical records of adult patients (n = 32) aged &gt;18 years with R\/R B-cell ALL treated with InO between February 2017 and October 2022 were assessed. Among the total study participants, 59.4% (n = 19) achieved CR\/CRi. Of these responders, MRD negativity was achieved in 94.7% (n = 18\/19), and 68.4% (n = 13\/19) achieved deep responses (MRD negative CR\/CRi) after a median of two cycles of InO. The median DOR for those achieving CR\/CRi was 6 months. Of the entire cohort, 34.4% (11\/32) of the participants proceeded to hematopoietic stem cell transplantation (HSCT). The OS rates at 6 and 12 months in the entire cohort were 46.9% and 28.1%, respectively. The median relapse-free survival (RFS) among the responders was 7 months. Grade 3\/4 treatment-related liver toxicity following InO initiation was reported in 37.5% of the participants. Myelosuppression-related adverse events were observed in 87.5% of the recipients.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>The real-world study (RWS) highlights the effectiveness of InO in achieving remission and MRD negativity in R\/R B-cell ALL, although treatment-related toxicities remain a concern.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fonc.2025.1601782","type":"journal-article","created":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T04:17:19Z","timestamp":1757477839000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A retrospective analysis of inotuzumab ozogamicin usage in adult patients with relapsed\/refractory B-cell acute lymphoblastic leukemia"],"prefix":"10.3389","volume":"15","author":[{"given":"Narendra","family":"Agrawal","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pavan K.","family":"Boyella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Bhargava","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chandran K.","family":"Nair","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arijit","family":"Nag","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,9,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2020.08.023","article-title":"Systematic review of the burden and treatment patterns of adult and adolescent acute lymphoblastic leukemia in India: comprehending the challenges in an emerging economy","volume":"21","author":"Radhakrishnan","year":"2021","journal-title":"Clin Lymphoma Myeloma Leuk"},{"key":"B2","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1055\/s-0041-1731860","article-title":"Inotuzumab ozogamicin monotherapy as an outpatient salvage treatment in relapsed refractory B-cell acute lymphoblastic leukemia: compassionate access","volume":"42","author":"Radhakrishnan","year":"2021","journal-title":"Ind J Med Paediatr Oncol"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-2399","article-title":"Inotuzumab ozogamicin for relapsed\/refractory acute lymphoblastic leukemia in the INO-VATE trial: CD22 pharmacodynamics, efficacy, and safety by baseline CD22","volume":"27","author":"Kantarjian","year":"2021","journal-title":"Clin Cancer Res"},{"key":"B4","doi-asserted-by":"publisher","first-page":"85","DOI":"10.2991\/chi.d.190503.002","article-title":"Treatment of adult patients with relapsed\/refractory B-cell philadelphia-negative acute lymphoblastic leukemia","volume":"1","author":"Maffini","year":"2019","journal-title":"Clin Hematol Int"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.28136","article-title":"Results of inotuzumab ozogamicin, a CD22 monoclonal antibody, in refractory and relapsed acute lymphocytic leukemia","volume":"119","author":"Kantarjian","year":"2013","journal-title":"Cancer"},{"key":"B6","doi-asserted-by":"publisher","first-page":"67","DOI":"10.2147\/JBM.S136575","article-title":"Inotuzumab ozogamicin in the treatment of relapsed\/refractory acute B cell lymphoblastic leukemia","volume":"9","author":"Uy","year":"2018","journal-title":"J Blood Med"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.14031","article-title":"Results of the compassionate program of inotuzumab ozogamicin for adult patients with relapsed or refractory acute lymphoblastic leukemia in Spain","volume":"111","author":"Torrent","year":"2023","journal-title":"Eur J Haematol"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1182\/blood.v124.21.2255.2255","article-title":"A phase II study of weekly inotuzumab ozogamicin (InO) in adult patients with CD22-positive acute lymphoblastic leukemia (ALL) in second or later salvage","volume":"124","author":"Advani","year":"2014","journal-title":"Blood"},{"key":"B9","doi-asserted-by":"publisher","first-page":"556","DOI":"10.1016\/j.clml.2020.03.004","article-title":"Real-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with inotuzumab ozogamicin","volume":"20","author":"Badar","year":"2020","journal-title":"Clin Lymphoma Myeloma Leuk"},{"key":"B10","doi-asserted-by":"publisher","first-page":"5905","DOI":"10.1182\/blood-2023-178448","article-title":"Inotuzumab use: A single-center experience in B-cell acute lymphoblastic leukemia. 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