Pembrolizumab for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndrome+3 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the safety of giving the drug pembrolizumab to people who have had a stem cell transplant to treat their cancer. Pembrolizumab will be given at a fixed dose of 200 mg IV (into a vein) every 3 weeks. Up to 26 patients will be enrolled in this trial.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Classical Hodgkin's Lymphoma
  • Non-Hodgkin Lymphoma
  • Acute Myeloid Leukemia

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From start date of therapy to the date of death from any cause, whichever may come first, assessed up to 100 months

24 months
Compare PD-L1 expression on malignant cells at initial diagnosis and at disease relapse following alloSCT
Effect of pembrolizumab on the T cell receptor (TCR) repertoire in the peripheral blood, and where available, tumor environment, following alloSCT
Effect of pembrolizumab on the numbers and activations status of peripheral blood T cells
Effect on restoring donor chimerism
Number of patients with adverse events
Month 100
Time between initial response and subsequent disease progression or relapse
Month 100
Time between the start of therapy to death from any cause.
Month 100
Time between first documentation of complete remission (CR) or partial remission (PR) (by IRC) to the first documentation of disease progression or death by any cause

Trial Safety

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Pembrolizumab
1 of 1

Experimental Treatment

26 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase < 1

Pembrolizumab
Drug
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start date of therapy to the date of death from any cause, whichever may come first, assessed up to 100 months

Who is running the clinical trial?

University of ChicagoLead Sponsor
925 Previous Clinical Trials
753,306 Total Patients Enrolled
Justin Kline, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
80 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects have undergone alloSCT > 90 days prior to enrollment from a matched-related donor (MRD), matched-unrelated donor (MUD), cord blood donor, or haplo-identical and cord blood donor.
Subjects must be willing and able to comply with the study requirements.
You are eligible for this study if you are at least 18 years of age.
Subjects must have an ECOG performance status of 0-1 (Appendix).