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NCT03913559
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
Phase 2 trial testing Inotuzumab ozogamicin in Acute Lymphoblastic Leukemia in 5 participants. Terminated before completion.
15 September 2025
Quick facts
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 14 May 2019 |
| Primary completion | 15 September 2025 |
| Estimated completion | 15 September 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Inotuzumab ozogamicin — full drug profile →
- Methotrexate
- Hydrocortisone
- Cytarabine — full drug profile →
- Diphenhydramine (diphenhydramine) — full drug profile →
- Acetaminophen
- Methylprednisolone (methylprednisolone) — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
St. Jude Children's Research Hospital
Who can join
Under 21, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients. Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL. Primary Objective * Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL with 0.1 - 4.99% blasts in bone marrow. Secondary Objectives * Study the safety of inotuzumab ozogamicin when used in patients with MRD - positive CD22+ B-ALL with \< 5 % blasts in bone marrow. * Estimate the incidence, severity, and outcome of hepatotoxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in patients during inotuzumab ozogamicin and following subsequent treatment, including hematopoietic stem cell transplant (HSCT).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting CD22 for the Treatment of B-Cell Malignancies.
Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546 -
Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806 -
The Role of Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Leukemia.
Algeri M, Merli P, Locatelli F, Pagliara D. · · 2021 · cited 28× · PMID 34501237 · DOI 10.3390/jcm10173790 -
Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies.
Kyriakidis I, Vasileiou E, Rossig C, Roilides E, et al · · 2021 · cited 24× · PMID 33807678 · DOI 10.3390/jof7030186 -
Inotuzumab ozogamicin in B-cell precursor acute lymphoblastic leukemia: efficacy, toxicity, and practical considerations.
Rubinstein JD, O'Brien MM. · · 2023 · cited 20× · PMID 37600823 · DOI 10.3389/fimmu.2023.1237738 -
An overview of antibody-drug conjugates in oncological practice.
Theocharopoulos C, Lialios PP, Gogas H, Ziogas DC. · · 2020 · cited 20× · PMID 33088347 · DOI 10.1177/1758835920962997 -
Antibody-Drug Conjugates for the Treatment of Acute Pediatric Leukemia.
Stokke JL, Bhojwani D. · · 2021 · cited 19× · PMID 34441852 · DOI 10.3390/jcm10163556 -
Advances in immunotherapeutic targets for childhood cancers: A focus on glypican-2 and B7-H3.
Li N, Spetz MR, Li D, Ho M. · · 2021 · cited 15× · PMID 33992682 · DOI 10.1016/j.pharmthera.2021.107892
Verify or expand the search:
- PubMed search for NCT03913559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Inotuzumab ozogamicin
Trials testing the same drug.
- NCT06554626 — Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL · Phase 2 · recruiting
- NCT06427330 — Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia · Phase 2 · recruiting
- NCT06387121 — Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL · Phase 2 · recruiting
- NCT05645718 — Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed · Phase 2 · recruiting
- NCT05748171 — A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With Firs · Phase 2 · recruiting
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Currently open trials in the same condition.
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Other St. Jude Children's Research Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03913559 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
- Last refreshed: 12 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03913559.
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