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Anti-metabolites

Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant

Phase 2
Waitlist Available
Led By Scott Solomon, MD
Research Sponsored by Northside Hospital, 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 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to help AML patients who can't get donor transplants. It uses chemotherapy, the patient's own stem cells, and a drug called pembrolizumab to boost the immune system's ability to fight leukemia. Pembrolizumab is an immunotherapy drug that has been used to treat various cancers by enhancing the immune system's ability to target and destroy cancer cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With 2-year Relapse Risk
Secondary study objectives
Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lymphodepletion plus PembrolizumabExperimental Treatment3 Interventions
Fludarabine \& Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Melphalan
2008
Completed Phase 3
~1500
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,044 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,781 Total Patients Enrolled
Scott Solomon, MDPrincipal InvestigatorBlood and Marrow Transplant Group of Georgia
6 Previous Clinical Trials
20,209 Total Patients Enrolled
~2 spots leftby Dec 2025
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