← Back to Search

Reactivator of Tumor Suppressor Protein p53

APR-548 + Azacitidine for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by Aprea Therapeutics
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, approximately 1 year
Awards & highlights

Study Summary

This study is evaluating whether a drug which is already approved for other uses may help treat a type of blood cancer.

Eligible Conditions
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 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
To investigate the safety and tolerability of APR-548 as monotherapy and in combination with azacitidine.

Side effects data

From 2023 Phase 1 trial • 48 Patients • NCT02038777
67%
Pyrexia
67%
Pneumonia
33%
Enteritis infectious
33%
Hyperaesthesia teeth
33%
Nausea
33%
Infective tenosynovitis
33%
Bronchitis
33%
Bacteraemia
33%
Rhinitis
33%
Blood creatine phosphokinase increased
33%
Prothrombin time prolonged
33%
Dysgeusia
33%
Muscle spasms
33%
Auricular chondritis
33%
Small intestinal haemorrhage
33%
Malaise
33%
Oedema
33%
Influenza
33%
Nasopharyngitis
33%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy Cohort: PF-04449913 25 mg
Monotherapy Cohort: PF-04449913 50 mg
Monotherapy Cohort: PF-04449913 100 mg
Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg
Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin
Combination Cohort 3: PF-04449913 100 mg + Azacitidine
Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg
Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Dose level 3
Group II: Cohort 2Experimental Treatment1 Intervention
Dose level 2
Group III: Cohort 1Experimental Treatment1 Intervention
Dose level 1

Find a Location

Who is running the clinical trial?

Aprea TherapeuticsLead Sponsor
13 Previous Clinical Trials
830 Total Patients Enrolled
Joachim Gullbo, MDStudy DirectorTheradex Oncology
2 Previous Clinical Trials
38 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)
2021. "APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04638309.
~1 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top