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DEC-C and Thioguanine for R/R AML - Trial NCT06351306

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.

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NCT06351306
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.govNCT06351306
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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)

Study Focus

Acute Myeloid Leukemia

Thioguanine (Tabloid ®)

Interventional

drug

Sponsor & Location

Joseph Jurcic

Columbia University

New York, United States of America

Timeline & Enrollment

Phase 2

Jan 30, 2024

Dec 01, 2027

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 leukaemia
Acute myeloblastic leukaemia [AML]
Myeloid leukaemia, unspecified
Acute myelomonocytic leukaemia
Acute myeloid leukaemia with 11q23-abnormality

Data Source

ClinicalTrials.gov

NCT06351306

Non-Device Trial