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Anti-metabolites

Safety Lead-In for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Joseph G. Jurcic, MD

Research Sponsored by Joseph Jurcic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial aims to determine if giving oral decitabine-cedazuridine with thioguanine is effective and safe for patients with acute myeloid leukemia that has come back or not

Who is the study for?

This trial is for patients with acute myeloid leukemia (AML) whose disease has returned or hasn't responded to previous treatments. The study aims to ensure participants can handle the highest safe dose of medications.Check my eligibility

What is being tested?

The study tests if oral decitabine-cedazuridine (Inqovi®) combined with thioguanine (Tabloid®) is effective and tolerable for AML patients. It's a phase II trial that starts by confirming the safety of the maximum dose before proceeding.See study design

What are the potential side effects?

Potential side effects may include nausea, vomiting, low blood cell counts leading to increased infection risk, liver issues, and mouth sores. The lead-in part of the trial will assess these risks at high doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Complete Remission (CRc) Rate

Secondary outcome measures

Duration of Remission

Overall Survival (OS)

Time to Complete Remission (CR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Safety Lead-InExperimental Treatment2 Interventions

Groups of participants will receive different doses of thioguanine and decitabine-cedazuridine to identify the highest doses that can be given safely. The highest doses that are safe will then be used in the phase II portion of the clinical trial. If no dose is found to be safe, the study will be stopped. A phase II expansion cohort will be enrolled to further explore the combination's anti-leukemia activity and safety and will proceed at the maximum tolerated dose defined in the initial Safety Cohort.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Joseph JurcicLead Sponsor

2 Previous Clinical Trials

2 Total Patients Enrolled

Joseph G. Jurcic, MDPrincipal InvestigatorColumbia University

4 Previous Clinical Trials

92 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"As detailed on clinicaltrials.gov, this research endeavor is actively seeking suitable participants. The trial was published on January 30th, 2024 and last revised on April 2nd, 2024."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that recruitment is ongoing for this investigation. The trial was first listed on January 30, 2024 and most recently revised on April 2, 2024. A total of 48 individuals are sought from a single site."

Answered by AI

What is the safety profile of the Safety Lead-In method for patients?

"Given that Safety Lead-In is a Phase 2 trial without efficacy data but with some safety information, it has been rated as a 2 on our scale of assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DEC-C and Thioguanine for R/R AML

Joseph Jurcic 2024. "DEC-C and Thioguanine for R/R AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351306.

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