Decitabine/cedazuridine

DRUG5 trials

Sponsors

Jacqueline Garcia, MD, Astex Pharmaceuticals, Inc., National Cancer Institute (NCI), H. Lee Moffitt Cancer Center and Research Institute, M.D. Anderson Cancer Center

Conditions

Acute Myeloid Leukemia (AML)BRCA1-Associated Protein-1 (BAP1) MutationsChronic Myelomonocytic Leukemia (CMML)Early-stage BAP1-associated MalignanciesEarly-stage MesotheliomaHematopoietic Stem Cell TransplantMDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable)Malignant Mesothelioma (MM)

Phase 1

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

Active, not recruitingNCT03613532

Jacqueline Garcia, MDAcute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), Hematopoietic Stem Cell Transplant +2

Start: 2018-10-24End: 2027-03-01Updated: 2025-12-24

Avapritinib With Decitabine in Patients With SM-AHN

RecruitingNCT06327685

H. Lee Moffitt Cancer Center and Research InstituteSystemic Mastocytosis With an Associated Hematologic Neoplasm

Start: 2024-03-13End: 2027-03-01Target: 34Updated: 2026-04-01

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

RecruitingNCT06445959

M.D. Anderson Cancer CenterMutant IDH1 Inhibitor Olutasidenib

Start: 2024-08-29End: 2029-06-30Target: 78Updated: 2025-10-24

Phase 2

A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)

TerminatedNCT05835011

Astex Pharmaceuticals, Inc.Myelodysplastic Syndromes

Start: 2023-06-27End: 2023-08-21Updated: 2024-10-02

Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

SuspendedNCT05960773

National Cancer Institute (NCI)BRCA1-Associated Protein-1 (BAP1) Mutations, Early-stage BAP1-associated Malignancies, Early-stage Mesothelioma +3

Start: 2024-01-31End: 2027-12-01Updated: 2026-03-27

Related Papers

Venetoclax/FluBu2 RIC transplant followed by all-oral venetoclax/decitabine maintenance for poor risk MDS/AML.

2025-12-05

Ven+FluBu2 with ptcy/tac/MMF RIC transplant followed by venetoclax/azacitidine maintenance for high-risk MDS/AML

Blood2025-11-03

Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial

Journal of Hematology & Oncology2025-01-1610 citations

Feasibility, Safety and Efficacy of Oral Maintenance Therapy with Venetoclax Plus Decitabine/Cedazuridine after Venetoclax Plus FluBu2 for High Risk MDS/AML Undergoing RIC Allo-HCT

Blood2024-11-05

A Phase 1 Study of Avapritinib in Combination with Decitabine in Patients with Systemic Mastocytosis with an Associated Hematologic Neoplasm

Blood2024-11-05

Prophylactic maintenance with venetoclax/azacitidine after reduced-intensity conditioning allogeneic transplant for high-risk MDS and AML

Blood Advances2024-01-1028 citations

Maintenance Therapy with Venetoclax/Azacitidine Can be Safely Given after Venetoclax/FluBu2 RIC Allogeneic Transplantation for the Treatment of High Risk MDS/AML: Results of a Phase 1 Study

Blood2022-11-152 citations

Adding venetoclax to fludarabine/busulfan RIC transplant for high-risk MDS and AML is feasible, safe, and active

Blood Advances2021-10-1041 citations