LeukemiaPhase 3NCT00454168
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
A Phase 3 study testing PR1 leukemia peptide vaccine and sargramostim in people with Leukemia, run by The Vaccine Company at 15 sites in United States.
Trial summary
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- PR1 leukemia peptide vaccine and sargramostim
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy must not be severely limited by other diseases
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin < 2 mg/mL
- ALT < 2 times upper limit of normal
- Creatinine ≤ 1.6 mg/mL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Antineutrophil cytoplasmic antibody negative
- No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient
- No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast
- No known allergy to incomplete Freund's adjuvant
- No hypercalcemia
- No progressive viral or bacterial infection
- Must be afebrile for 7 days without antibiotics
- No symptomatic cardiac disease
- LVEF ≥ 40%
- No symptomatic pulmonary disease
- FEV_1, FVC, and DLCO ≥ 50% of predicated (without bronchodilator)
- No history of HIV positivity or AIDS
- No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product
- No history of Wegener's granulomatosis or vasculitis
PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery and/or radiotherapy
- No prior allogeneic or syngeneic stem cell transplantation
- No prior solid organ transplantation
- No prior vaccine therapy for AML
- More than 28 days since prior chronic use (> 2 weeks) of corticosteroids > 10 mg/day (prednisone [or equivalent])
- Concurrent topical or inhaled corticosteroids allowed
- More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus
- No concurrent radiotherapy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, 46237
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Cancer Care Centers of South Texas - Southeast
San Antonio, Texas, 78222
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Vaccine Company
South San Francisco, California, 94080
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.
Read the detailed description
OBJECTIVES:
Primary
- Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CSF.
Secondary
- Compare improvement of relapse-free survival of patients treated with these regimens.
- Compare remission duration in patients treated with these regimens.
- Compare immune response, as measured by PR1-HLA-A2 tetramer assay, in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to age and complete remission (CR) (≥ 18 years of age and in second CR vs ≥ 55 years of age and in first CR), type of acute myeloid leukemia (de novo vs secondary), and cytogenetics (unfavorable vs favorable and intermediate). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously (SC).
- Arm II: Patients receive placebo vaccine and GM-CSF SC.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- PR1 leukemia peptide vaccine, sargramostim, placebo
- Keywords
- adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4), adult acute promyelocytic leukemia (M3), secondary acute myeloid leukemia, adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Promyelocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR1 leukemia peptide vaccineBiological
Given subcutaneously
sargramostimBiological
Given subcutaneously
placeboOther
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously. Receives: Biological: PR1 leukemia peptide vaccine; Biological: sargramostim |
| Arm II | Active comparator | Patients receive placebo vaccine and GM-CSF subcutaneously. Receives: Biological: sargramostim; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (3)
Relapse-free survival
Remission duration
Immune response as measured by PR1-HLA-A2 tetramer assay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startMay 2005
- Primary completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Vaccine Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Craig S. Rosenfeld, MD, Study chair, The Vaccine Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454168
- Sponsor's protocol ID
- CDR0000510853
- Other IDs
- VACCINE-PR1-104, UCCRC-14613B
- Status last verified
- Feb 2009
- First submitted
- 27 Mar 2007
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study
- ClinicalTrials.gov ID
- NCT00454168
- Acronym / sponsor ID
- CDR0000510853
- Conditions
- Leukemia
- Keywords
- adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- The Vaccine CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Apr 2009 (estimated)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.
Detailed description
OBJECTIVES:
Primary
- Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CSF.
Secondary
- Compare improvement of relapse-free survival of patients treated with these regimens.
- Compare remission duration in patients treated with these regimens.
- Compare immune response, as measured by PR1-HLA-A2 tetramer assay, in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to age and complete remission (CR) (≥ 18 years of age and in second CR vs ≥ 55 years of age and in first CR), type of acute myeloid leukemia (de novo vs secondary), and cytogenetics (unfavorable vs favorable and intermediate). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously (SC).
- Arm II: Patients receive placebo vaccine and GM-CSF SC.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: PR1 leukemia peptide vaccine, Biological: sargramostimPatients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously. |
| Arm II | Active comparator | Biological: sargramostim, Other: placeboPatients receive placebo vaccine and GM-CSF subcutaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PR1 leukemia peptide vaccineGiven subcutaneously | Biological | Arm I |
| sargramostimGiven subcutaneously | Biological | Arm I, Arm II |
| placeboGiven subcutaneously | Other | Arm II |
Primary outcome
Overall survival
3 secondary outcomes
Relapse-free survival
Remission duration
Immune response as measured by PR1-HLA-A2 tetramer assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig S. Rosenfeld, MD study chair
The Vaccine Company
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PR1 leukemia peptide vaccine and sargramostim in people with Leukemia, run by The Vaccine Company at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.