Randomized, Double-Blind Phase III Clinical Trial Comparing Outcomes of Immunologic Autograft Engineering Versus Standard Autograft Collection in Patients Undergoing Autologous Stem Cell Transplantation for Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Median Progression-free Survival
研究概览
简要总结
RATIONALE: It is not yet known which method of stem cell collection is best for patients undergoing an autologous stem cell transplant.
PURPOSE: This randomized phase III trial is comparing two different methods of collecting stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the therapeutic effect of instrument-driven lymphocyte enrichment of the autograft absolute lymphocyte count (A-ALC) compared to "standard autograft collection" as determined by progression-free survival post-transplantation.
Secondary
- Determine the profile of immune effector cells of the "lymphocyte enriched autograft" vs "standard autograft" and peripheral blood after autologous stem cell transplant (ASCT) and their impact on post- ASCT immunological reconstitution and clinical endpoints.
- Perform quantitative and functional analysis of T, B, NK, and dendritic cells from the apheresis product and peripheral blood samples at multiple timepoints after transplantation.
- Determine and compare the proportion of patients who are progression-free and alive at 1 and 2 years.
- Determine the differences in overall survival between the two collection method arms.
- Evaluate and characterize differences in transplantation outcomes (e.g., time to ALC engraftment, incidence of infection, and the CD34 count) between the two collection method arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of diffuse large cell lymphoma
- •Low-grade non-Hodgkin lymphoma transformed to diffuse large cell lymphoma allowed
- •Candidate for with autologous peripheral blood stem cell transplantation
- •Not requiring bone marrow harvest to collect stem cells
- •No chemotherapy with filgrastim ( G-CSF) or mobilization study drug (i.e., AMD3100) needed for mobilization of stem cells
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Cardiac and pulmonary status sufficient to undergo apheresis and stem cell transplantation
- •Negative pregnancy test
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No active uncontrolled infection requiring antibiotic treatment
- •No comorbid condition which, in view of the investigators, renders the patient at high risk from treatment complications
- •Willing to provide all research blood samples as required by the protocol
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for the purpose of this study)
- •More than 4 weeks since prior experimental therapy
- •No concurrent enrollment on another experimental protocol during the mobilization phase
- •No concurrent participation in any autologous stem cell transplantation study that is not using the standard conditioning regimens for lymphomas
排除标准
- 未提供
研究组 & 干预措施
Immunologic autograft engineering
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients undergo ASCT IV on the day of apheresis (lymphocyte enriched autograft).
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
Immunologic autograft engineering
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients undergo ASCT IV on the day of apheresis (lymphocyte enriched autograft).
干预措施: leukapheresis (Procedure)
Standard autograft collection
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0). Patients undergo ASCT IV on the day of apheresis.
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
Standard autograft collection
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0). Patients undergo ASCT IV on the day of apheresis.
干预措施: leukapheresis (Procedure)
结局指标
主要结局
Median Progression-free Survival
时间窗: Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.
Progression free survival (PFS) was defined as the time from the date of infusion to disease progression, relapse, or death from any cause. Patients alive without disease progression or relapse were censored at their last disease evaluation or at their secondary primary cancer diagnosis, whichever occurred first. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node \>1.0 cm in its short axis or in the sum of the products of diameters (SPD) of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm). A log rank test was used to assess whether PFS differed with respect to apheresis collection method.
次要结局
- Progression-free Survival Rate at 2 Years(Date of infusion to disease progression, relapse, or death from any cause, up to two years)
- Median Number of CD34 Cells/kg Infused(5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater)
- One-year Overall Survival Rate(date of infusion to death from any cause, up to one year)
- Progression-free Survival Rate at 1 Year(Date of infusion to disease progression, relapse, or death from any cause, up to one year)
- Median Time to Absolute Lymphocyte Count Engraftment(Up to 30 days after autologous peripheral hematopoietic stem cell transplantation)