NCT06351306

DEC-C and Thioguanine for R/R AML

A Phase II Open-Label, Single Center Trial of Oral Decitabine-Cedazuridine (DEC-C) (Inqovi®) in Combination With Thioguanine (Tabloid®) in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe.

Detailed description

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow with a 5-year survival rate of 47.5% for patients less than age 65 years and only an 8.2% survival for those 65 and older, based on data from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. Despite some advances in treatment, most patients will relapse, and treatment remains limited, especially for patients that progress on the standard of care. The expected response rate to salvage chemotherapy is only 10-20% with a median survival typically of less than 6 months. The need for new, effective, and well-tolerated treatments is clear.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Thioguanine (Tabloid ®)	60-80mg/m\^2 oral tablet
DRUG	DecitabineCedazuridine (Inqovi ®)	35 mg decitabine and 100 mg cedazuridine oral tablet

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-04-08
• Last updated: 2025-03-24

Regulatory

• FDA-regulated drug study