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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 | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT06297629•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.

Detailed Description

Primary Objectives * To determine the safety and toxicity of ASTX727 with or without donor lymphocyte infusion (type, frequency, severity of adverse events \[AEs\] and relationship of AEs to ASTX727) in the study population (cohort #1 and cohort #2). * To estimate the complete response (CR) rate of ASTX727 with or without donor lymphocyte infusion (DLI) for the eradication of minimal residual disease (MRD) in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), after hematopoietic stem cell transplantation (cohort #1). * Estimate relapse-free survival (RFS) with the use of ASTX727 as maintenance therapy in participants with high-risk AML and MDS after study entry following hematopoietic stem cell transplantation (cohort #2). Secondary Objectives * Participants with creatinine clearance 40-60 cc/min at enrollment will be observed and reported for safety and toxicity separately. * To determine the overall response and response duration in cohort #1, in participants with MRD detected in the post-transplant setting. * Duration of remission after study entry following allogeneic stem cell transplant for cohort #2. * To determine incidence of acute and chronic graft versus host disease (GvHD) * To evaluate overall survival (OS). Exploratory Objective * To investigate possible relationships between protein and gene expression signatures/mutation profile and DNA methylation in predicting relapse-free survival time to the ASTX727. * To gain insight into clinically relevant genomic factors influencing transplant outcomes, especially into the mechanism of relapse after transplant. * To characterize the composition of different T-cell subsets, and to determine how those correlate with each other and with transplant outcomes.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of AML and MDS according to World Health Organization (WHO) classification that underwent first or second allogeneic HSCT with either peripheral blood or bone marrow as the source of the hematopoietic stem cells.
•Age 18 to 75 years old.
•High risk patients defined per cohorts as below:
•Cohort #1: AML and MDS patients in morphological remission with persistence or reappearance of MRD by flow cytometry or molecular after allogeneic stem cell transplantation who are beyond day 100 after allogeneic stem cell transplantation.
•* When MRD is detected by flow cytometry, disease level at or above the sensitivity level of the test will be required.
•* MRD level at or above 0.1%.
•* When MRD is detected by molecular testing, disease level at or above the sensitivity level of the test will be required.
•* The limit of detection is 0.01%
•Cohort #2: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing within 100 days after allogeneic stem cell transplantation.
•MDS patients:
+24 more criteria

Exclusion Criteria

•Use of any anti-leukemic agents after MRD is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-Azacytidine or FLT3 inhibitors for maintenance, for cohort #1 patients. However, all those agents will be discontinued once the patient enrolls into the current trial for cohort #1.
•Use of any of the following after transplantation and prior to starting study therapy for cohort #2. Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous or oral 5-Azacytidine or FLT3 inhibitors for maintenance).
•Overall grade II-IV acute GVHD. However, upon complete resolution of acute GVHD-related symptoms, patients are eligible for enrollment if they are on prednisone 0.5 mg/kg daily dose or lower, tacrolimus, sirolimus and ruxolitinib.
•Chronic GvHD, moderate or severe by NIH criteria.
•Active uncontrolled systemic fungal, bacterial or viral infection. However, patients receiving anti-microbial agents including antibiotics, antiviral and antifungal therapies are allowed if hemodynamically stable.
•Symptomatic or uncontrolled arrhythmias.
•Significant active cardiac disease within the previous 6 months, including:
•New York Hear Association (NYHA) class III or IV congestive heart failure;
•Unstable angina or angina requiring surgical or medical intervention, and/or; Myocardial infarction.
•Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
+9 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

July 1, 2024

Primary Completion Date

July 11, 2024

Completion Date

July 11, 2024

Last Updated

February 24, 2026

Conditions

Allogeneic Stem Cell Transplantation

Interventions

ASTX727

DRUG

Donor Lymphocyte Infusion

DRUG

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Patients Undergoing Allogeneic Stem Cell Transplantation

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TERMINATEDPHASE1

Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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