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NCT06668584
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
Phase 2 trial testing Olutasidenib in Myeloid Malignancies in 31 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 31 December 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Olutasidenib (OLUTASIDENIB) — full drug profile →
Conditions studied
- Myeloid Malignancies — all drugs for Myeloid Malignancies →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 18 to 75, any sex, with Myeloid Malignancies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort.
Cortes J, Curti A, Fenaux P, Jonas BA, et al · · 2025 · cited 2× · PMID 41239466 · DOI 10.1186/s13045-025-01751-w
Verify or expand the search:
- PubMed search for NCT06668584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Olutasidenib
Trials testing the same drug.
- NCT07411586 — Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia · Phase 1 · not yet recruiting
- NCT07153497 — Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-R · Phase 2 · not yet recruiting
- NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
- NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
- NCT07304011 — Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leuke · Phase 2 · recruiting
Other recruiting trials for Myeloid Malignancies
Currently open trials in the same condition.
- NCT07396480 — Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic He · Phase 3 · recruiting
- NCT06930651 — A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Kn · Phase 1, PHASE2 · recruiting
- NCT06383572 — Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Che · Phase 1, PHASE2 · recruiting
- NCT05796570 — A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combine · Phase 2 · 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
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT06668584 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 4 March 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/NCT06668584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing