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Anti-metabolites

Group 1 for Stem Cell Transplant

Phase 2

Waitlist Available

Led By Betul Oran, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

"This trial aims to see if ASTX727 alone or with donor lymphocyte infusion can effectively treat certain blood cancers after a stem cell transplant."

Who is the study for?

This trial is for individuals who have undergone a stem cell transplant and are now dealing with certain types of blood cancers. Participants should meet specific health criteria set by the researchers to ensure they can safely receive the treatments being tested.Check my eligibility

What is being tested?

The study is testing ASTX727, an oral medication, alone or combined with donor lymphocyte infusion (DLI), to see if it can control blood-based cancers after a stem cell transplant. It's in early stages (Phase I/II) to assess effectiveness and safety.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with cancer medications such as nausea, fatigue, low blood counts leading to increased infection risk, and possible complications from DLI like graft-versus-host disease.

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

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

If participants do not test positive for MRD, you will be enrolled in Group 2. Participants in this group will only receive ASTX727. If participants are enrolled in Group 2, the participant will take ASTX727 on Days 1-3 of each cycle.

Group II: Group 1Experimental Treatment2 Interventions

If participants test positive for minimal residual disease (MRD), participants will be enrolled in Group 1. MRD refers to small numbers of cancer cells that remain in the body during or after treatment. Participants in this group will receive ASTX727 and DLI. If participants are enrolled in Group 1, the participant will take ASTX727 on Days 1-4 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donor Lymphocyte Infusion

1995

Completed Phase 2

~50

ASTX727

2018

Completed Phase 3

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Industry Sponsor

95 Previous Clinical Trials

7,896 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,737 Total Patients Enrolled

Betul Oran, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

61 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 Group 2 received FDA authorization?

"Based on our assessment, the safety rating for Group 2 is a 2. This evaluation is due to being in Phase 2 of the trial where there exists some evidence supporting safety but not yet efficacy."

Answered by AI

Are potential participants still able to enroll in this ongoing trial?

"The data available on clinicaltrials.gov shows that this investigation is presently not open for participant recruitment. Despite being initially listed on 7/31/2024 and last updated on 3/6/2024, it should be noted that there are currently 2716 other studies actively seeking volunteers."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this study?

"Individuals eligible for inclusion in this study must have undergone a stem cell transplantation and be between 18 and 75 years of age. The trial aims to enroll a total of 65 participants."

Answered by AI

Is there a provision for participants below the age of 18 in this clinical study?

"Patients between the ages of 18 and 75 are sought for participation in this clinical trial. Notably, there exist a total of 359 investigations targeting individuals under 18 years old and another 2502 studies focused on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

2024. "A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06297629.

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