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Anti-metabolites

Safety Run In Phase (only Cohort 1): for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Ivana Gojo, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 3-28 day cycles
Awards & highlights

Study Summary

This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase) of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule of AZA selected for this study is FDA approved for patients with MDS/AML.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-28 day cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-28 day cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal Tolerable Dose of Pembrolizumab for Cohort 1
Secondary outcome measures
Number of Participants Who Had Complete Remission/Complete Remission With Incomplete Recovery

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Run In Phase (only Cohort 1):Experimental Treatment2 Interventions
The treatment of relapsed and refractory AML patients.
Group II: Cohort 2Experimental Treatment2 Interventions
The treatment of newly diagnosed AML patients (≥ 65 years) who are not candidates for intensive induction chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Azacitadine
2016
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,853 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,016 Total Patients Enrolled
Ivana Gojo, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
76 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
Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients
2016. "Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02845297.
~8 spots leftby Apr 2025
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