Faculty, Staff and Student Publications
Language
English
Publication Date
2-1-2024
Journal
Blood
DOI
10.1182/blood.2023022330
PMID
37879077
Abstract
The detection of measurable residual disease (MRD) is the strongest predictor of relapse in acute lymphoblastic leukemia (ALL). Using inotuzumab ozogamicin in the setting of MRD may improve outcomes. Patients with ALL in first complete remission (CR1) or beyond (CR2+) with MRD ≥ 1 × 10-4 were enrolled in this phase 2 trial. Inotuzumab was administered at 0.6 mg/m2 on day 1 and 0.3 mg/m2 on day 8 of cycle 1, then at 0.3 mg/m2 on days 1 and 8 of cycles 2-6. Twenty-six consecutive patients with a median age of 46 years (range, 19-70 years) were treated. Nineteen (73%) were in CR1 and seven (27%) in CR2+; 16 (62%) had Philadelphia chromosome-positive ALL. Fifteen (58%) had baseline MRD ≥ 1 × 10-3. A median of 3 cycles (range, 1-6) were administered. Eighteen (69%) patients responded and achieved MRD negativity. After a median follow-up of 24 months (range, 9-43), the 2-year relapse-free survival rate was 54% and the 2-year overall survival rate was 60% in the entire cohort. Most adverse events were low grade; sinusoidal obstruction syndrome was noted in 2 patients (8%). In summary, inotuzumab ozogamicin resulted in favorable survival, MRD negativity rates, and safety profiles for patients with ALL and MRD-positive status. This study was registered at www.ClinicalTrials.gov as #NCT03441061.
Keywords
Humans, Young Adult, Adult, Middle Aged, Aged, Inotuzumab Ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Hepatic Veno-Occlusive Disease, Neoplasm, Residual
Published Open-Access
yes
Recommended Citation
Jabbour, Elias; Haddad, Fadi G; Short, Nicholas J; et al., "Phase 2 Study of Inotuzumab Ozogamicin for Measurable Residual Disease in Acute Lymphoblastic Leukemia in Remission" (2024). Faculty, Staff and Student Publications. 5544.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/5544
Included in
Bioinformatics Commons, Biomedical Informatics Commons, Genetic Phenomena Commons, Medical Genetics Commons, Oncology Commons