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NCT06235801
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Phase 1, PHASE2 trial testing Gilteritinib in Myeloid Leukemia in 20 participants. Currently enrolling.
1 October 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 22 May 2024 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 October 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gilteritinib (GILTERITINIB) — full drug profile →
- Momelotinib — full drug profile →
Conditions studied
- Myeloid Leukemia — all drugs for Myeloid Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
AXL as immune regulator and therapeutic target in Acute Myeloid Leukemia: from current progress to novel strategies.
Vandewalle N, De Beule N, De Becker A, De Bruyne E, et al · · 2024 · cited 7× · PMID 39367387 · DOI 10.1186/s40164-024-00566-8
Verify or expand the search:
- PubMed search for NCT06235801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gilteritinib
Trials testing the same drug.
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- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07032727 — Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Act · Phase 2 · recruiting
- NCT06734585 — Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant · completed
- NCT06561880 — The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation · Phase 1, PHASE2 · recruiting
Other recruiting trials for Myeloid Leukemia
Currently open trials in the same condition.
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- NCT05194397 — Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors · Phase 2 · recruiting
- NCT05035706 — Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors · EARLY_PHASE1 · active not recruiting
- NCT04260022 — Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL · Phase 1 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
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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 NCT06235801 (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 M.D. Anderson Cancer Center
- Last refreshed: 19 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/NCT06235801.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing