Trial reportHaematologica2025
Efficacy and safety of currently approved and lower starting doses of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukemia: a phase IV study.
Trial report in Haematologica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03677596 (A PHASE 4, OPEN-LABEL, RANDOMIZED STUDY OF TWO INOTUZUMAB OZOGAMICIN DOSE LEVELS IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA ELIGIBLE FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION AND WHO HAVE RISK FACTOR), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
A phase 4, open-label, randomized study of two inotuzumab ozogamicin dose levels in adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia eligible for hematopoietic stem cell transplantation and who have risk factor(s) for veno-occlusive disease
Who cites it
3 citing papers in PubMed.
- Outcomes by Body Mass Index in Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin.Targeted oncology · 2026Article
- Incorporating Immunotherapies into the Evolving Standard of Care for Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia.Paediatric drugs · 2026Review
- Chronic portal hypertension following inotuzumab ozogamicin in a low-risk patient: a case of overriding baseline risk and long-term management.Annals of hematology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Inotuzumab ozogamicin (InO) is approved for treatment of relapsed/refractory acute lymphoblastic leukemia (R/R ALL). Previous studies reported higher rates of post-hematopoietic stem cell transplant (HSCT) hepatic sinusoidal obstruction syndrome (SOS) in patients receiving InO than in those receiving chemotherapy prior to HSCT. It is unknown whether a lower InO dose would reduce the risk of post-HSCT SOS or affect efficacy. This study evaluated efficacy and safety of the currently approved InO starting dose and a lower dose in adults with R/R ALL who were eligible for HSCT and were identified as being at higher risk of post-HSCT SOS. This open-label, phase IV study (NCT03677596) had two phases: in the run-in phase patients received InO at 1.2 mg/m2/cycle (N=22); in the randomized phase patients received InO starting at dose levels of 1.8 mg/m2/cycle (N=38) or 1.2 mg/m2/cycle (N=42). Primary endpoints were rate of SOS and rate of hematologic remission. Overall, SOS was reported in ten patients (9.8%) and in all cases was post-HSCT SOS. In patients who proceeded to HSCT, post-HSCT SOS rates were 20%, 28.6%, 25.8%, and 16.7% in 1.2 mg/m2/cycle (run-in), 1.2 mg/m2/cycle (randomized), 1.2 mg/m2/cycle (run-in and randomized), and 1.8 mg/m2/cycle (randomized) InO dosing subgroups, respectively. The rates of complete remission with or without complete hematologic recovery were 50.0%, 83.3%, 71.9%, and 68.4% in the respective subgroups. The study found that a starting dose of the 1.2 mg/m2/cycle demonstrated efficacy and safety consistent with those of the recommended 1.8 mg/m2/ cycle dose in adults with R/R ALL who were eligible for HSCT and had a higher risk of post-HSCT SOS.
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