A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Nucleated Cells Collected Within the Apheresis Products
研究概览
简要总结
No prospective randomized trials have evaluated the most efficacious dose of cyclophosphamide to mobilize autologous stem cells. We previously demonstrated that the time to collection of autologous hematopoietic stem cells is 10-12 days following the one dose of cyclophosphamide and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of apheresis required and resource utilization.
详细描述
This prospective randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of apheresis required and resource utilization.
The time to collection of autologous hematopoietic stem cells was ten to twelve days following cyclophosphamide and daily filgrastim. Peripheral blood CD34+ cell numbers were examined beginning ten days after cyclophosphamide administration. Leukapheresis began once the blood CD34+ number reached 10 cells/mcl. Patients received consecutive days of leukapheresis, with the goal of collecting > 5 x 106 CD34+cells/kg. The collection process, concentration and storage of PBSC were similar for all patients. Briefly, a 4-blood volume leukapheresis PBSC collection was performed daily using a COBE Spectra cell separator (COBE BCT, Lakewood, CO). Collected cells were concentrated and cryopreserved. Cells were frozen in Cryocyte freezing bags (Nexell Therapeutics Inc.) in a controlled rate freezer (Custom BioGenic Systems, Shelby Township, MI). At the conclusion of this freezing, the cells were transferred to the vapor phase of a monitored liquid nitrogen freezer (CryoPlus III, Forma Scientific, Marietta, OH) at a temperature of -120 0C or below.
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
- None
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
- •All patients must have a pathologic diagnosis of one of the following malignancies:
- •Non-Hodgkin's Lymphoma, including B- and T-cell lymphoma Multiple Myeloma or another plasma cell dyscrasia (Waldenstrom, Amyloidosis)
- •The patient must be approved for transplant by the treating Transplant physician.
- •This must be the patient's FIRST mobilization attempt.
- •Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells.
- •Prior Treatment: No previous cytotoxic chemotherapy within 4 weeks prior to initiation of therapy. (This does not include immunomodulatory drugs (IMiDs), proteasome inhibitors, monoclonal antibodies or steroids.)
- •No radiation within 4 weeks of mobilization attempt.
- •Age >18, and < 75 years
- •No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
- •Informed consent must be signed prior to the treatment. Patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. (Human protection committee approval of this protocol and a consent form is required.)
排除标准
- •Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy.
- •Documented hypersensitivity to any of the drugs used in the protocol.
研究组 & 干预措施
Arm 2: Cyclophosphamide 3 gms/m(2)
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
干预措施: Cyclophosphamide (Drug)
Arm 1: 1.5 gms/m(2) Cyclophosphamide
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of Nucleated Cells Collected Within the Apheresis Products
时间窗: 6 weeks
the investigator will identify the number of cells collected within the apheresis products
Number of CD34+ Cells Collected Within the Apheresis Products
时间窗: 6 weeks
the investigator will identify the number of CD34+ cells collected within the apheresis products
次要结局
- Resource Utilization - Transfusions of Red Blood Cells(participants will be followed approximately 6 weeks following initiation of treatment)
- Resource Utilization- Transfusion of Platelets(participants will be followed approximately 6 weeks following initiation of treatment)
- Resource Utilization- Incidence of Febrile Neutropenia(participants will be followed approximately 6 weeks following initiation of treatment)
- Toxicities During the Mobilization and Apheresis Processes(participants will be followed approximately 6 weeks following initiation of treatment)
- Resource Utilization- Hospitalizations(participants will be followed approximately 6 weeks following initiation of treatment)
研究者
Kenneth Meehan
Director, Bone Marrow Transplant Program
Dartmouth-Hitchcock Medical Center