13 recruiting, 2 active not recruiting, 1 available. 12 Phase 1, 4 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Recruiting 10, Active not recruiting 2 |
| Phase 2 | 4 | Recruiting 3, Active not recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow Ziftomenib: new trials by email Literature Review of Ziftomenib trials Research Report on Ziftomenib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Acute Myeloid Leukemia | Phase 2 | Recruiting | Uma Borate | 70 | 2026-10-01 | 2026-08-27 |
| Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML Ziftomenib, Mezigdomide - KMT2A-rearranged, NPM1-mutant Refractory or Relapsed AML | Phase 1 | Recruiting | Massachusetts General Hospital | 24 | 2026-09-02 | 2026-10-08 |
| Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia Ziftomenib, Olutasidenib - Acute Myeloid Leukemia | Phase 1 | Active not recruiting | M.D. Anderson Cancer Center | 32 | 2026-05-28 | 2026-08-24 |
| A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia ziftomenib - Acute Myeloid Leukemia (AML) | Phase 2 | Recruiting | Kyowa Kirin Co., Ltd. | 6 | 2026-04-23 | 2026-06-03 |
| Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML Ziftomenib, Placebo, Venetoclax - Acute Myeloid Leukemia (AML) | Phase 3 | Recruiting | Kura Oncology, Inc. | 1300 | 2025-09-26 | 2026-10-13 |
| Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia Ziftomenib, Quizartinib - Acute Myeloid Leukemia | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 44 | 2025-07-10 | 2026-09-18 |
| A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) ziftomenib, imatinib mesylate - Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer | Phase 1 | Recruiting | Kura Oncology, Inc. | 135 | 2025-03-27 | 2026-10-27 |
| Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia Ziftomenib, Cytarabine, Fludarabine - Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia | Phase 1 | Recruiting | PedAL BCU, LLC | 20 | 2025-03-18 | 2026-10-09 |
| A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia Venetoclax, Gemtuzumab, Ziftomenib - Acute Myeloid Leukemia | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 22 | 2025-03-07 | 2026-06-12 |
| A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias Ziftomenib, Venetoclax, Azacitidine - Refractory Acute Leukemia, Pediatric Relapsed | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 22 | 2024-12-27 | 2026-09-03 |
| Ziftomenib Maintenance Post Allo-HCT Ziftomenib - Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission | Phase 1 | Recruiting | Massachusetts General Hospital | 22 | 2024-06-11 | 2026-10-06 |
| Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia Ziftomenib, Fludarabine, Idarubicin - AML, AML With Mutated NPM1 | Phase 1 | Recruiting | Kura Oncology, Inc. | 171 | 2024-02-22 | 2026-08-20 |
| TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II Dexamethasone, Mitoxantrone, PEG asparaginase - Lymphoblastic Leukemia | Phase 1 / Phase 2 | Recruiting | Tanja Andrea Gruber | 90 | 2023-11-03 | 2026-06-03 |
| A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML Ziftomenib, Venetoclax, Azacitidine - Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation | Phase 1 | Recruiting | Kura Oncology, Inc. | 420 | 2023-07-18 | 2026-03-13 |
| First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Ziftomenib, Midazolam, Itraconazole - Advanced Malignant Neoplasm, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Active not recruiting | Kura Oncology, Inc. | 263 | 2019-09-12 | 2026-05-13 |
| Expanded Access to Ziftomenib ziftomenib - Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations | Available | Kura Oncology, Inc. | 2026-06-29 |
Leukemia, Myeloid, Acute (12) · Hematologic Neoplasms (4) · Leukemia (4) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (3) · Gastrointestinal Stromal Tumors (1) · Leukemia, Biphenotypic, Acute (1) · Leukemia, Myeloid (1) · Neoplasms by Histologic Type (1) · Recurrence (1) · Sarcoma, Myeloid (1)
Kura Oncology, Inc. (6) · M.D. Anderson Cancer Center (4) · Massachusetts General Hospital (2) · Kyowa Kirin Co., Ltd. (1) · PedAL BCU, LLC (1) · Tanja Andrea Gruber (1) · Uma Borate (1)
United States (14) · Canada (4) · Italy (4) · Spain (4) · France (3) · Belgium (2) · Germany (2) · Australia (1) · Austria (1) · Czechia (1) · Greece (1) · Hungary (1) · Japan (1) · Netherlands (1) · Philippines (1)
Amir Fathi, MD (1) · Branko Cuglievan, MD (1) · Courtney DiNardo, MD (1) · David McCall, MD (1) · Ghayas Issa, MD (1) · Tanja A Gruber, MD, PhD (1) · Uma M Borate, MBBS, MD, MSc (1) · Zachariah DeFilipp, MD (1)
PMID 33741715, PMID 34267079, PMID 39362248, PMID 40997296, PMID 41671463, PMID 42227701
2023 (1), 2025 (1)