Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkin's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Disease-free survival at 2 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving filgrastim together with chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of transplantation in patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma when treated with filgrastim (G-CSF) followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood stem cell (PBSC) transplantation.
- Determine whether sufficient PBSC can be collected for use in autologous transplantation in these patients when mobilized with hematopoietic growth factor alone compared to chemotherapy plus growth factor.
- Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic recovery after transplantation in these patients.
- Compare the numbers of committed progenitor cells and/or primitive, pluripotential hematopoietic stem cells with these two priming techniques.
- Compare the numbers of tumor cells in cryopreserved PBSC following these priming techniques.
- Evaluate response and extended relapse free survival in conjunction with rapid hematopoietic reconstitution and limited transplant associated morbidity and mortality in these patients when treated with these regimens.
OUTLINE: In the first priming phase, patients receive filgrastim (G-CSF) subcutaneously (SQ) daily on days 1-7 and peripheral blood stem cells are collected on days 6-8.
At least 48 hours after the last dose of G-CSF and after the third leukapheresis, patients receive the second priming, which consists of cyclophosphamide IV over 2 hours on day 1 and cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1. Patients also receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of 4 doses on days 1-2. Patients receive G-CSF SQ daily beginning on day 4 and continuing until the completion of leukapheresis. PBSC are collected on 3 consecutive days after blood counts recover.
In the transplant phase, patients with non-Hodgkin's lymphoma who have not exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice daily on days -4 through -1. Autologous PBSC are reinfused on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover.
研究设计
- 研究类型
- Interventional
- 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
- •No complete response after 12 weeks of initial combination chemotherapy
- •Bulky disease (greater than 10 cm nodal masses or mediastinal disease involving greater than 1/3 of the chest diameter
- •Malignant pleural effusion
- •Liver involvement
- •LDH greater than 2 times upper limit of normal at diagnosis
- •At least 2 extranodal sites
- •Low grade non-Hodgkin's lymphoma:
- •Follicular small cleaved cell lymphoma
- •Follicular mixed cell lymphoma
- •Diffuse small lymphocytic lymphoma
- •In first or greater complete response OR
- •Following initial treatment if complete response is not achieved
- •In second or greater complete or partial response if treated at diagnosis without clinical symptoms necessitating treatment
- •T-cell lymphoma (nonlymphoblastic, intermediate, or high grade lymphomas) after initial therapy whether or not complete response is achieved
- •Hodgkin's lymphoma
- •Stage I and II disease treated with primary radiotherapy and failure of at least one combination chemotherapy regimen
- •Stage III and IV disease with failure on mechlorethamine, vincristine, procarbazine, and prednisone (MOPP)-like regimen, alternative noncross resistant regimen (e.g., doxorubicin, bleomycin, vinblastine, and dacarbazine [ABVD]), or a combination (e.g., MOPP-ABV)
- •High risk features allowed including:
- •Failure to achieve initial complete remission with MOPP and/or ABVD and crossover or hybrid therapy
- •Relapse within 6 months after initial therapy
- •Relapse after initial radiotherapy with complete response longer than 1 year since initial therapy and subsequent failure on MOPP and/or ABVD or hybrid
- •Bulky mediastinal disease after initial therapy and residual mass of at least 5 cm with other features of persisting disease (e.g., Gallium scan positive, high LDH, enlarging on serial x-rays, or positive biopsy)
- •No HIV or HTLV-1 associated lymphomas
- •No resistant or refractory lymphoma (no partial response following up to 3 courses of combination chemotherapy)
- •No active ischemic or degenerative CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •70 and under
- •Performance status:
- •Age 65-70 years:
- •Karnofsky 80-100%
- •Under 65 years:
- •ECOG 0-1 (2 allowed if symptoms are directly related to lymphoma)
- •Life expectancy:
- •Greater than 8 weeks
- •Hematopoietic:
- •Not specified
- •No prior or current chronic liver disease
- •Bilirubin no greater than 1.5 mg/dL
- •AST and alkaline phosphatase less than 2 times normal
- •Age 65-70 years:
- •Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- •Under 65 years:
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •LVEF at least 45% by MUGA
- •No symptoms of cardiac disease
- •No active ischemic heart disease
- •No uncontrolled hypertension
- •Age 65-70 years:
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 2 years
次要结局
- Relapse or progression transplant related mortality at 1½ years