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NCT05940961
Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL
Phase 2 trial testing Inotuzumab Ozogamicin in ALL in 42 participants. Currently enrolling.
1 August 2026
Quick facts
| Lead sponsor | Sheng-Li Xue, MD |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 August 2022 |
| Primary completion | 1 August 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Inotuzumab Ozogamicin — full drug profile →
Conditions studied
- ALL — all drugs for ALL →
- MRD-positive — all drugs for MRD-positive →
- Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →
Sponsor
Sheng-Li Xue, MD — full company profile →
Who can join
Adults 15 to 65, any sex, with ALL or MRD-positive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high. MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Inotuzumab ozogamicin in adult acute lymphoblastic leukemia: Development, current status, and future directions.
Kantarjian HM, Boissel N, Papayannidis C, Luskin MR, et al · · 2024 · cited 13× · PMID 39093036 · DOI 10.1002/cncr.35505 -
Naked antibodies and antibody-drug conjugates: targeted therapy for childhood acute lymphoblastic leukemia.
Brivio E, Bautista F, Zwaan CM. · · 2024 · cited 9× · PMID 38832425 · DOI 10.3324/haematol.2023.283815 -
Adapting measurable residual disease evaluation to clinical practice for patients with acute lymphoblastic leukemia who underwent allogeneic stem cell transplantation.
Chen Y, Li S, Zhao X, Chang Y. · · 2025 · PMID 41229975 · DOI 10.21147/j.issn.1000-9604.2025.05.02
Verify or expand the search:
- PubMed search for NCT05940961
- 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.
- NCT06287229 — Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients · Phase 1, PHASE2 · recruiting
- NCT06087419 — A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Ve · Phase 1, PHASE2 · unknown
- NCT05597085 — A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again · completed
- NCT07238907 — A Multi-center Retrospective Study of INO Treating B-ALL · active not recruiting
- NCT05016947 — Venetoclax Plus Inotuzumab for B-ALL · Phase 1 · active not recruiting
Other recruiting trials for ALL
Currently open trials in the same condition.
- NCT07252336 — A Multicenter Study of CAR-T Cells in Primary Ph+All · Phase 2 · recruiting
- NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
- NCT05476770 — Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies · Phase 1 · recruiting
- NCT05016947 — Venetoclax Plus Inotuzumab for B-ALL · Phase 1 · active not recruiting
- NCT04644016 — Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders · Phase 2 · recruiting
Other Sheng-Li Xue, MD trials
Trials by the same sponsor.
- NCT05901974 — Venetoclax Combined With Azactidine in the Treatment of ALAL · Phase 2 · recruiting
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 NCT05940961 (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 Sheng-Li Xue, MD
- Last refreshed: 21 November 2025
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/NCT05940961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing