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Anti-metabolites
Oral Decitabine/Cedazuridine + Magrolimab for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
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 approximately 44 months
Awards & highlights
Study Summary
This trial tests whether a new drug combo is safe and effective to treat leukemia.
Eligible Conditions
- Myelodysplastic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 44 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) Rate
Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Number of Participants With Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Area Under the Plasma Concentration-Time Curve (AUC) of Oral Decitabine/Cedazuridine and Magrolimab
Duration of Progression Free Survival (PFS)
Duration of Response (DOR)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Oral Decitabine/Cedazuridine + MagrolimabExperimental Treatment2 Interventions
Participants will receive 35 milligrams (mg) decitabine/100 mg cedazuridine as a fixed dose combination (FDC) tablet, orally, once daily (QD) on Days 1-5 of each 28-day cycle in combination with magrolimab, intravenous (IV) infusion of 1 milligrams per kilogram (mg/kg) on Days 1 and 4, 15 mg/kg on Day 8, 30 mg/kg on Days 11, 15, 22, 29, 36, 43, and 50, followed by a maintenance dose of 30 mg/kg on Day 57 and every 14 days thereafter until toxicity, progressive disease, withdrawal, death or end of study (approximately 44 months).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magrolimab
2021
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,861 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have known or suspected allergies to decitabine, cedazuridine, magrolimab, or any of the ingredients in these medications.There is a strong belief that your central nervous system (brain and spinal cord) is currently affected by a condition called MDS.You have received treatment for MDS with chemotherapy, a stem cell transplant from a donor, or at least one full cycle of a medication called HMA.You have had a type of blood disorder called therapy-related MDS or MDS that developed from another blood disease.You have previously been treated with a drug that targets CD47.You have a bleeding disorder that needs medication or medical treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Decitabine/Cedazuridine + Magrolimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a risk of adverse reactions to the combination treatment of Oral Decitabine/Cedazuridine and Magrolimab?
"Our team at Power assigned Oral Decitabine/Cedazuridine + Magrolimab a score of 2, as this Phase 2 trial has some evidence for safety but none yet to back up its efficacy."
Answered by AI
How many individuals have been enrolled in this trial to date?
"Yes, as per clinicaltrials.gov records, this trial is still seeking to add participants into its cohort. It was first published on June 1st 2023 and last modified on the 29th of same month. A total of 100 people will be accepted from two different sites."
Answered by AI
Is this trial currently taking on new participants?
"Clinicaltrials.gov states that this medical trial is actively enrolling patients, which commenced in June 1st 2023 and was recently updated on the 29th of the same month."
Answered by AI
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