Active, not recruitingInterventional · Phase 2NCT03722407 ↗A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion
Active, not recruitingInterventional · Phase 1/2NCT04067336 ↗A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid LeukemiaGail J RobozPIInterventionDrug: Ziftomenib · Drug: Midazolam · Drug: ItraconazoleDatesSep 2019 – Oct 2028 (est.)SponsorKura OncologyAdvanced Malignant NeoplasmAcute Myeloid LeukemiaMixed Lineage Leukemia+4 more
RecruitingInterventional · Phase 2/3NCT04256317 ↗A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)Gail J RobozPIInterventionDrug: Azacitidine · Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Cedazuridine · Drug: VenetoclaxDatesMay 2020 – Nov 2027 (est.)SponsorAstex Pharmaceuticals, Inc.Myelodysplastic SyndromesAcute Myeloid LeukemiaMyelodysplastic Syndrome/Neoplasm+1 more
RecruitingInterventional · Phase 1NCT05735184 ↗Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid LeukemiaGail J RobozPIInterventionDrug: Ziftomenib · Drug: Venetoclax · Drug: Azacitidine · Drug: Daunorubicin · Drug: Cytarabine · Drug: QuizartinibDatesJul 2023 – Apr 2030 (est.)SponsorKura OncologyAcute Myeloid LeukemiaMixed Lineage Leukemia Gene MutationRefractory AML+7 more
RecruitingInterventional · Phase 1NCT06001788 ↗Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid LeukemiaGail J RobozPIInterventionDrug: Ziftomenib · Drug: Fludarabine · Drug: Idarubicin · Drug: Cytarabine · Drug: Gilteritinib · Biological: Granulocyte colony-stimulating factorDatesFeb 2024 – Dec 2026 (est.)SponsorKura OncologyAMLAML With Mutated NPM1Hematologic Malignancy+9 more
RecruitingInterventional · Phase 2NCT06824168 ↗A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete RemissionPinkal DesaiPIInterventionDrug: Quizartinib High Dose · Drug: Quizartinib Low DoseDatesJul 2025 – Jun 2028 (est.)SponsorDaiichi Sankyo, Inc.Acute Myeloid LeukemiaLeukemia
RecruitingInterventional · Phase 3NCT07007312 ↗Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid LeukemiaGail J RobozPIInterventionDrug: Ziftomenib · Drug: Placebo · Drug: Venetoclax · Drug: Azacitidine (AZA) · Drug: Daunorubicin · Drug: Cytarabine (Ara-C)DatesSep 2025 – Nov 2031 (est.)SponsorKura OncologyAcute Myeloid Leukemia (AML)
RecruitingInterventional · Phase 2NCT07216443 ↗A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic SyndromeAlexandra Gomez ArteagaPIInterventionBiological: Orca-TDatesDec 2025 – Nov 2027 (est.)SponsorOrca BiosystemsLeukemia, Myeloid, AcuteMyelodysplastic SyndromesMixed Phenotype Acute Leukemia
CompletedInterventional · Phase 1/2NCT02158858 ↗A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myeloproliferative Neoplasms)Joseph M ScanduraPIInterventionDrug: Pelabresib · Drug: RuxolitinibDatesJul 2014 – Jan 2025· Results postedSponsorConstellation PharmaceuticalsMyelofibrosisLeukemia, Myelocytic, AcuteMyelodysplastic/Myeloproliferative Neoplasm+11 more
TerminatedInterventional · Phase 1/2NCT03176277 ↗A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic SyndromesGail J RobozPIInterventionDrug: ONO-7475 3mg once daily · Drug: ONO-7475 6mg once daily · Drug: ONO-7475 10mg once daily · Drug: ONO-7475 6mg + Venetoclax (70-400mg)DatesJun 2017 – Dec 2022· Results postedSponsorOno Pharmaceutical Co., LtdAcute LeukemiaMyelodysplastic Syndromes
CompletedInterventional · Phase 1NCT03393611 ↗A Pilot Study of a Novel Sequential Treatment Utilizing CPX-351 as Salvage Chemotherapy Followed by Allogeneic Stem-Cell Transplantation (SCT) Utilizing a Haplo-cord Graft for Patients With Relapsed or Refractory Leukemia or Myelodysplastic SyndromeSebastian A. MayerPIInterventionDrug: CPX-351 · Drug: Fludarabine · Drug: Melphalan · Drug: Rabbit Anti-Human T-Lymphocyte Globulin · Biological: Haplo-Cord Stem Cell TransplantationDatesNov 2012 – Aug 2021SponsorWeill Medical College of Cornell UniversityMyelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Relapsed Adult Acute Myeloid+1 more
TerminatedInterventional · Phase 1NCT05787496 ↗A Phase 1, Open-Label, Safety, Tolerability, And Efficacy Study of NC525 in Subjects With Advanced Myeloid NeoplasmsPinkal DesaiPIInterventionDrug: NC525DatesFeb 2023 – Jan 2025· Results postedSponsorNextCure, Inc.Relapsed or Refractory Acute Myeloid LeukemiaRelapsed or Refractory Chronic Myelomonocytic LeukemiaRelapsed or Refractory Myelodysplastic Syndrome