← Back to Search

Anti-metabolites

Dose Escalation for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Abhishek Maiti, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Participants need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.

Participants ≥18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), with no available standard treatment options.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

"This trial aims to determine the best dose of HC-7366 to give alongside azacitidine and venetoclax to AML patients, while also assessing the safety and effectiveness of this drug

Who is the study for?

Adults (≥18 years) with relapsed or refractory Acute Myeloid Leukemia (AML), excluding acute promyelocytic leukemia, who have no standard treatment options left. They must understand the study and consent to it, have good liver and kidney function, use contraception, and may join post-bone marrow transplant under certain conditions.Check my eligibility

What is being tested?

The trial is testing a new drug combination for AML: HC-7366 with azacitidine and venetoclax. The goal is to determine the safest dose of HC-7366 that can be used alongside these drugs while assessing their combined effects on AML.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system, digestive issues like nausea or constipation, fatigue, possible impact on blood cell counts leading to increased infection risk or bleeding problems. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with AML or MDS/AML with 10-19% blasts.

Select...

I am over 18 with relapsed or refractory AML or MDS/AML, excluding APL, and no standard treatments are available for me.

Select...

My condition has returned or didn't respond to treatment.

Select...

My blood disorder has progressed to acute myeloid leukemia, and I am eligible for the dose escalation phase.

Select...

I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment3 Interventions

If you are found to be eligible to take part in this study, you will be assigned to a dose level of HC-7366 based on when you join this study. Participants enrolled will receive HC-3766 single agent during cycle 1. HC-3766 will be taken once daily while fasting, 1 hour before or 2 hours after a meal, on days 1-28. Cycles 2 and beyond: HC-3766 will be taken once daily while fasting, 1 hour before or 2 hours after a meal, on days 1-28. Azacitidine will be administered either intravenously or subcutaneously on days 1-7 of each cycle. Venetoclax will be taken on daily with water and a meal on days 1-28.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Azacitidine

2012

Completed Phase 3

~1440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,784 Total Patients Enrolled

HiberCell, Inc.Industry Sponsor

19 Previous Clinical Trials

862 Total Patients Enrolled

Abhishek Maiti, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

32 Total Patients Enrolled

Frequently Asked Questions

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

Has the Food and Drug Administration authorized dose escalation as a valid medical practice?

"Given that this is a Phase 1 trial, the safety rating for Dose Escalation would be relatively low at 1. Limited data is available to support both safety and efficacy at this stage of the study."

Answered by AI

Are there any available opportunities for patients to participate in this ongoing clinical trial?

"Per the details on clinicaltrials.gov, recruitment for this trial is currently inactive. The study was first listed on 8/31/2024 and last updated on 2/22/2024. Despite this trial not seeking participants presently, there are a total of 1515 other ongoing trials actively recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia

2024. "Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285890.