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Anti-metabolite

Azacitidine for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Naveen Pemmaraju
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 up to 5 years
Awards & highlights

Study Summary

This trial is studying PLX51107 and azacitidine to see how well they work compared to azacitidine alone in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Acute Myeloid Leukemia
  • Myeloproliferative Neoplasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Minimum safe and biologically effective dose
Secondary outcome measures
Duration of response
Event-free survival
Gene mutations in acute myeloid leukemia
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (BRD4 Inhibitor PLX51107, azacitidine)Experimental Treatment2 Interventions
Patients receive PLX51107 PO QD on days 1-21 and azacitidine SC or IV over 15 minutes on days 8-14 and 22-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
BRD4 Inhibitor PLX51107
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,624 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,759 Total Patients Enrolled
Naveen PemmarajuPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
90 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
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
2019. "PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04022785.
~8 spots leftby Apr 2025
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