To improve the tolerability of post-transplant maintenance and outcomes despite poor risk disease genetics, we conducted a phase 1 study of venetoclax/FluBu2 RIC transplantation with tacrolimus/methotrexate GVHD prophylaxis followed by all-oral venetoclax/decitabine-cedazuridine (ven/dec-c) maintenance in poor-risk MDS/AML patients (N=30). PROs assessed in first 6-months of maintenance were stable except for emotional function, which improved (P=0.008). Trial is registered at clinicaltrials.gov/NCT03613532.

8 days ago

Journal

TP53 (Tumor protein P53)

TP53 mutation

Venclexta (venetoclax) • methotrexate • Inqovi (decitabine/cedazuridine)

11d

Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes (clinicaltrials.gov)

P1/2, N=3, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Drug company withdrew support.

11 days ago

Trial termination

Inqovi (decitabine/cedazuridine) • eltanexor (KPT-8602)

18d

Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)

P1/2, N=209, Recruiting, Washington University School of Medicine | N=126 --> 209

18 days ago

Enrollment change

Inqovi (decitabine/cedazuridine)

19d

LANTana: Lutathera and ASTX727 in Neuroendocrine Tumours (clinicaltrials.gov)

P1, N=27, Recruiting, Imperial College London | Trial completion date: Dec 2025 --> Feb 2029 | Trial primary completion date: Dec 2025 --> Jun 2026

19 days ago

Trial completion date • Trial primary completion date

Inqovi (decitabine/cedazuridine) • Lutathera (lutetium Lu 177 dotatate)

NCI-2021-02246: Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients (clinicaltrials.gov)

P1/2, N=5, Active, not recruiting, National Cancer Institute (NCI) | N=55 --> 5 | Trial completion date: Oct 2025 --> Nov 2026 | Trial primary completion date: Oct 2025 --> Jun 2025

1 month ago

Enrollment change • Trial completion date • Trial primary completion date • Tumor mutational burden

BCL2 (B-cell CLL/lymphoma 2)

Venclexta (venetoclax) • cytarabine • daunorubicin • Inqovi (decitabine/cedazuridine) • Starasid (cytarabine ocfosfate)

Decitabine-cedazuridine in patients with MDS and TP53 mutations. (PubMed, Blood Adv)

Median survival was 13.1 months (95% CI: 8.4 - 21.3) for DEC-C vs 8.0 months (95% CI: 5.2 - 13.0) for single agent parenteral HMA (log-rank, p=0.047). In patients with MDS harboring TP53mut, DEC-C may improve overall survival compared to parenteral HMA.

1 month ago

Journal

TP53 (Tumor protein P53)

TP53 mutation • TP53 wild-type

Inqovi (decitabine/cedazuridine)

2ms

Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov)

P1, N=13, Active, not recruiting, OHSU Knight Cancer Institute | Suspended --> Active, not recruiting

2 months ago

Enrollment closed

TP53 (Tumor protein P53)

TP53 mutation

Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)

2ms

ASCENT1: Research Study Investigating How Well NDec Works in People With Sickle Cell Disease (clinicaltrials.gov)

P2, N=96, Completed, Novo Nordisk A/S | Active, not recruiting --> Completed | Trial primary completion date: Aug 2025 --> Dec 2024

2 months ago

Trial completion • Trial primary completion date

hydroxyurea • decitabine/ tetrahydrouridine (EPI01)

2ms

Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)

P1/2, N=8, Active, not recruiting, University of Colorado, Denver | Trial completion date: Jul 2026 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Oct 2025

2 months ago

Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker

CD4 (CD4 Molecule)

Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)