NCT06351306

DEC-C and Thioguanine for R/R AML

Name: Clinical Trial NCT06351306
Creator: Joseph Jurcic
Keywords: Acute Myeloid Leukemia, Thioguanine (Tabloid ®), Phase 2, drug, clinical trial, United States of America

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)

Joseph Jurcic·Phase 2·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Acute Myeloid Leukemia
Drug/Device/Intervention: Thioguanine (Tabloid ®)
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Joseph Jurcic
Funder: Columbia University
Location: New York, United States of America

Timeline & enrollment

Phase: Phase 2
Start date: Jan 30, 2024
End date: Dec 01, 2027
Enrollment: 48 participants

Primary outcome

Composite Complete Remission (CRc) Rate

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.

ICD-10 classifications

Myeloid leukaemiaAcute myeloblastic leukaemia [AML]Myeloid leukaemia, unspecifiedAcute myelomonocytic leukaemiaAcute myeloid leukaemia with 11q23-abnormality

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06351306
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06351306 through Pure Global AI's free database. This Phase 2 trial is sponsored by Joseph Jurcic and is currently Recruiting. The study focuses on Acute Myeloid Leukemia. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.