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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
Must not have
No prior vaccine therapy for AML
No concurrent radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not received a vaccine for acute myeloid leukemia.
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I am not currently undergoing radiotherapy.
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I have not had a stem cell transplant from a donor or twin.
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I have not had any organ transplant surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a vaccine for acute myeloid leukemia.I do not have any lung problems causing symptoms.I do not have acute promyelocytic leukemia in its first complete remission.I have never tested positive for HIV/AIDS.My life expectancy is not majorly reduced by other illnesses.I have fully recovered from any previous surgeries or radiation treatments.I am using corticosteroids that are applied to the skin or inhaled.My AML diagnosis is new and not linked to any previous blood disorders or treatments.My AML developed from a previous blood disorder or after exposure to cancer-causing agents.My leukemia is in the first complete remission and is classified as M0-M2 or M4-M7.I am HLA-A2 positive.It's been over 3 months since I last took experimental drugs or certain immune-suppressants.I am not currently undergoing radiotherapy.I am over 55 and in my first complete remission or over 18 and in my second, within the last month.My leukemia is in the second complete remission.My cancer has not spread outside the bone marrow.I do not have active leukemia in my brain or spinal cord.I am fully active or can carry out light work.I haven't had any cancer except for skin cancer or early-stage cervical/breast cancer in the last 5 years.- 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 vasculitisI have not had a stem cell transplant from a donor or twin.I have not had any organ transplant surgeries.I haven't taken high-dose steroids for more than 2 weeks in the last month.I have never had Wegener's granulomatosis or vasculitis.I had fatigue, bleeding, or infections for over a month before my AML diagnosis, confirmed by blood tests.I do not have any heart-related symptoms.I haven't had a fever for 7 days without taking antibiotics.I have been diagnosed with acute myeloid leukemia.I do not have any worsening viral or bacterial infections.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.