PR1 leukemia peptide vaccine for Leukemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Leukemia
PR1 leukemia peptide vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a vaccine made from a peptide as a possible treatment for acute myeloid leukemia. The vaccine is being given with colony-stimulating factors (such as GM-CSF) which increase the number of white blood cells and platelets. The trial will compare the vaccine given with GM-CSF to a placebo given with GM-CSF to see if the vaccine is more effective.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration:

Immune response as measured by PR1-HLA-A2 tetramer assay
Overall survival
Relapse-free survival
Remission duration

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm II
1 of 2
Arm I
1 of 2
Active Control
Experimental Treatment

244 Total Participants · 2 Treatment Groups

Primary Treatment: PR1 leukemia peptide vaccine · Has Placebo Group · Phase 3

Arm IExperimental Group · 2 Interventions: PR1 leukemia peptide vaccine, sargramostim · Intervention Types: Biological, Biological
Arm IIActiveComparator Group · 2 Interventions: sargramostim, placebo · Intervention Types: Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PR1 leukemia peptide vaccine
Not yet FDA approved
Sargramostim
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

The Vaccine CompanyLead Sponsor
3 Previous Clinical Trials
47 Total Patients Enrolled
2 Trials studying Leukemia
17 Patients Enrolled for Leukemia
Craig S. Rosenfeld, MDStudy ChairThe Vaccine Company
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a marrow blast count of less than 5%.
You have an FAB stage M0-M7 if you are in second CR.
You have a complete remission (CR) within the past month.
You have a history of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia.
You have no history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents.
You are in first CR.
You have a positive HLA-A2 allele.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.