Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.
PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.
详细描述
OBJECTIVES:
- Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma.
- Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy.
- Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo.
- Determine the relationships between length of culture, immunophenotype, and clinical outcome.
- Determine the required numbers of white blood cell precursors for clinical efficacy.
- Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.
OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.
Patients are followed monthly for 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven relapsed or refractory non-Hodgkin's lymphoma
- •Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation
- •No metastatic disease involving the bone marrow
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •No active hepatitis B or C
- •Bilirubin less than 2.5 times normal*
- •SGOT or SGPT less than 2.5 times normal*
- •Alkaline phosphatase less than 2.5 times normal NOTE: * Unless Gilbert's syndrome present
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •Cardiac ejection fraction normal
- •DLCO at least 50% predicted
- •FEV_1 and FVC at least 75% predicted
- •HIV negative
- •Not pregnant
- •Negative pregnancy test
- •No non-neoplastic disease that would preclude intensive chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior external beam radiotherapy to more than 25% of the active bone marrow
- •Not specified
排除标准
- 未提供