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NCT05404516
Combination of Sorafenib With Standard Therapy in Newly Diagnosed Adult CBF AML
Phase 2 trial testing Sorafenib in Core Binding Factor Acute Myeloid Leukemia in 88 participants. Status unknown.
31 August 2022
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 1 January 2020 |
| Primary completion | 31 August 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sorafenib (SORAFENIB) — full drug profile →
- Idarubicin (IDARUBICIN) — full drug profile →
- Cytarabine — full drug profile →
Conditions studied
- Core Binding Factor Acute Myeloid Leukemia — all drugs for Core Binding Factor Acute Myeloid Leukemia →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
Adults 18 to 65, any sex, with Core Binding Factor Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Core-binding factor acute myeloid leukemia accounts for 10-15% of AML and is categorized as favorable-risk AML. However, the 5-year CIR was up to 40% in this group of patients. Emerging data show that a high frequency of mutations and/or high expression of KIT in CBF AML. Sorafenib is a multitargeted TKI, thus the purpose of this study is to evaluate the safety and efficacy of sorafenib combined with standard therapy in CBF AML.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Proteomic Characterization of Acute Myeloid Leukemia for Precision Medicine.
Casado P, Cutillas PR. · · 2023 · cited 15× · PMID 36805445 · DOI 10.1016/j.mcpro.2023.100517 -
Improving long-term outcomes with intensive induction chemotherapy for patients with AML.
Röllig C. · · 2023 · cited 7× · PMID 38066853 · DOI 10.1182/hematology.2023000504
Verify or expand the search:
- PubMed search for NCT05404516
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sorafenib
Trials testing the same drug.
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- NCT06474663 — A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabi · Phase 1 · withdrawn
- NCT06690697 — Combination of Toripalimab and JS004 Therapy for ccRCC · Phase 2 · recruiting
- NCT06177496 — Influence of Sarcopenia in Hepatocellular Carcinoma Patients · unknown
- NCT05033522 — Immunotherapy for Advanced Liver Cancer · Phase 2, PHASE3 · suspended
Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
- NCT07091994 — A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy · Phase 4 · not yet recruiting
- NCT06444022 — hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation · Phase 1 · withdrawn
- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07481032 — Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients · NA · not yet recruiting
- NCT07511894 — Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer · Phase 2 · not yet 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 NCT05404516 (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 Nanfang Hospital, Southern Medical University
- Last refreshed: 3 June 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/NCT05404516.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing