Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

Masonic Cancer Center, University of Minnesota1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2000年8月最近更新: 2017年11月29日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Masonic Cancer Center, University of Minnesota
入组人数: 22
试验地点: 1
主要终点: Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

详细描述

OBJECTIVES:

Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 70 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
•Philadelphia chromosome positive OR
•BCR/ABL rearrangement
•Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
•70 and under
•Performance status:
•Age 65-70 years:
•Karnofsky 80-100%
•Under 65 years:
•Karnofsky 90-100%
•Age 65-70 years:
•Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
•Under 65 years:
•Not specified
•Cardiovascular:
•Age 65-70 years:
•LVEF at least 45%
•Pulmonary:
•Age 65-70 years:
•If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted
•Normal organ function (excluding bone marrow)

排除标准

•Blast crisis or post blast crisis
•Severe fibrosis defined by bilateral trephine biopsies
•Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy