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NCT03951961
Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation
Phase 2 trial testing Midostaurin in Acute Myeloid Leukemia, Adult in 1 participant. Terminated before completion.
28 February 2021
Quick facts
| Lead sponsor | University of Jena |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 20 March 2020 |
| Primary completion | 28 February 2021 |
| Estimated completion | 28 February 2021 |
| Sites | 4 locations across Germany |
Drugs / interventions tested
- Midostaurin (MIDOSTAURIN) — full drug profile →
Conditions studied
- Acute Myeloid Leukemia, Adult — all drugs for Acute Myeloid Leukemia, Adult →
Sponsor
University of Jena
Who can join
18 and older, any sex, with Acute Myeloid Leukemia, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The MAURITIUS trial is a single-arm, multicenter phase II study of single treatment with midostaurin being applied to AML (acute myeloid leukemia) patients with activating FLT3 (FMS-like tyrosine kinase3) mutations and either molecular relapse or persistent molecular positivity after allogeneic SCT. The leukemia-free survival (LFS), the achievement of "MRD low" as well as the incidence of GvHD after transplantation reflect the most relevant endpoints of this non-randomized clinical trial.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
<i>FLT3</i> Mutations in Acute Myeloid Leukemia: Key Concepts and Emerging Controversies.
Kennedy VE, Smith CC. · · 2020 · cited 132× · PMID 33425766 · DOI 10.3389/fonc.2020.612880 -
New Insights Into the Role of Phenotypic Plasticity and EMT in Driving Cancer Progression.
Bhatia S, Wang P, Toh A, Thompson EW. · · 2020 · cited 63× · PMID 32391381 · DOI 10.3389/fmolb.2020.00071 -
Midostaurin In Acute Myeloid Leukemia: An Evidence-Based Review And Patient Selection.
Abbas HA, Alfayez M, Kadia T, Ravandi-Kashani F, et al · · 2019 · cited 23× · PMID 31632141 · DOI 10.2147/cmar.s177894 -
Novel agents targeting leukemia cells and immune microenvironment for prevention and treatment of relapse of acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.
Shi W, Jin W, Xia L, Hu Y. · · 2020 · cited 15× · PMID 32837873 · DOI 10.1016/j.apsb.2020.06.012
Verify or expand the search:
- PubMed search for NCT03951961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Midostaurin
Trials testing the same drug.
- NCT06313437 — Revumenib in Combination With 7+3 + Midostaurin in AML · Phase 1 · recruiting
- NCT04982354 — Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia · Phase 1, PHASE2 · withdrawn
- NCT05488613 — Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) · completed
- NCT04496999 — HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. · Phase 1 · terminated
- NCT04075747 — A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia · Phase 1 · completed
Other recruiting trials for Acute Myeloid Leukemia, Adult
Currently open trials in the same condition.
- NCT06652438 — Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML · Phase 3 · recruiting
- NCT06532552 — Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Ne · Phase 2 · recruiting
- NCT06199557 — A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients · Phase 1, PHASE2 · recruiting
- NCT05703126 — Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML · NA · recruiting
- NCT05133882 — A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML · Phase 1, PHASE2 · recruiting
Other University of Jena trials
Trials by the same sponsor.
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- NCT05814874 — Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources · NA · completed
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- NCT05067465 — Nutritional Biomarker Screening for Defined Food Groups · NA · completed
- NCT04902937 — Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell · 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 NCT03951961 (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 University of Jena
- Last refreshed: 21 January 2022
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/NCT03951961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing