NCT00454168Unknown3 期
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
The Vaccine Company30 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2005年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 244
- 试验地点
- 30
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Remission duration
- Relapse-free survival
- Immune response as measured by PR1-HLA-A2 tetramer assay
研究者
研究点 (30)
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