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Cancer Vaccine

Vaccine Therapy + GM-CSF for Leukemia

Phase 3
Waitlist Available
Research Sponsored by The Vaccine Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of acute myeloid leukemia (AML), defined by the presence of > 20% blasts in marrow or blood, including the following subtypes: De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents; Secondary AML, defined as the following: AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure; 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; In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 18 years of age) within the past month; FAB stages M0-M2 and M4-M7 allowed if in first CR; No acute promyelocytic leukemia in first CR; FAB stages M0-M7 allowed if in second CR; Marrow blast count < 5% (≤ 200 nucleated cell count); No blasts in blood; HLA-A2 positive at 1 allele; No extramedullary disease; No Auer rods; No active meningeal or CNS leukemia
No symptomatic pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) who are in their first or second remission, have a specific immune system marker (HLA-A2), and whose major organs are functioning well. They should not be pregnant, must use contraception if fertile, and cannot have had certain other treatments or conditions like HIV/AIDS.Check my eligibility
What is being tested?
The study is testing whether a vaccine made from an AML peptide combined with GM-CSF (a white blood cell booster) helps the immune system kill cancer cells better than a placebo combined with GM-CSF. Participants will be randomly assigned to one of these two options.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, bone pain due to increased white blood cells, and potentially allergic reactions to components of the vaccine or GM-CSF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any lung problems causing symptoms.
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I do not have acute promyelocytic leukemia in its first complete remission.
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I have never tested positive for HIV/AIDS.
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- You can perform daily activities without any difficulty (ECOG performance status 0-1) - You are not expected to have a limited life expectancy due to other health conditions - You have enough white blood cells and platelets - Your liver and kidney function are within normal range - You are not pregnant, breastfeeding or planning to have a baby - You are not allergic to incomplete Freund's adjuvant - You don't have any serious medical condition or psychiatric illness that may affect your participation in the study or increase your risk - You don't have any other cancer except for some specific types - You don't have any active infection or high fever - You don't have any serious heart or lung disease - You don't have HIV or AIDS - You are not allergic to sargramostim (GM-CSF) or yeast-derived products - You don't have a history of Wegener's granulomatosis or vasculitis
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My AML diagnosis is new and not linked to any previous blood disorders or treatments.
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My AML developed from a previous blood disorder or after exposure to cancer-causing agents.
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I am HLA-A2 positive.
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My cancer has not spread outside the bone marrow.
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I do not have active leukemia in my brain or spinal cord.
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I am fully active or can carry out light work.
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I have never had Wegener's granulomatosis or vasculitis.
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I do not have any heart-related symptoms.
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I haven't had a fever for 7 days without taking antibiotics.
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I have been diagnosed with acute myeloid leukemia.
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I do not have any worsening viral or bacterial infections.

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IExperimental Treatment2 Interventions
Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.
Group II: Arm IIActive Control2 Interventions
Patients receive placebo vaccine and GM-CSF subcutaneously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PR1 leukemia peptide vaccine
Not yet FDA approved
Sargramostim
FDA approved

Find a Location

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

Media Library

PR1 leukemia peptide vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00454168 — Phase 3
Leukemia Research Study Groups: Arm I, Arm II
Leukemia Clinical Trial 2023: PR1 leukemia peptide vaccine Highlights & Side Effects. Trial Name: NCT00454168 — Phase 3
PR1 leukemia peptide vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00454168 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial being offered in more than one hospital?

"This trial is taking place at 15 different institutions, for example University of Chicago Cancer Research Center, Greenebaum Cancer Center at University of Maryland Medical Center, and Cancer Care Centers of South Texas - Southeast."

Answered by AI

When might the PR1 leukemia peptide vaccine be cleared by the FDA?

"PR1 leukemia peptide vaccine is safe, as evidenced by its Phase 3 clinical trial status."

Answered by AI

Are there any other ongoing research initiatives using PR1 leukemia peptide vaccine?

"There are currently 43 clinical trials studying the efficacy of PR1 leukemia peptide vaccines, 5 of which are in Phase 3. The majority of these studies are based in Seattle, but there are a total of 1885 hospitals and research centres running trials for this treatment worldwide."

Answered by AI

What is the main objective of PR1 leukemia peptide vaccine?

"The PR1 leukemia peptide vaccine has shown promise in treating severe infection, lymphoma, hodgkins, and bone marrow transplantation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
2005. "Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00454168.
All > Acute Myeloid Leukemia > Leukemia
~12 spots leftby Apr 2025
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