NCT00002700已完成3 期
A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4)
European Organisation for Research and Treatment of Cancer - EORTC87 个研究点 分布在 10 个国家目标入组 392 人开始时间: 1995年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 87
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Compare the remission induction, toxicity, and duration of remission in patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma treated with prednisone vs dexamethasone plus cyclophosphamide, daunorubicin, and vincristine as induction.
- Compare the survival and disease-free survival of patients treated with autologous bone marrow transplantation (BMT) followed by low- or high-intensity maintenance chemotherapy with cranial irradiation after consolidation.
- Determine the relative and disease-free survival of patients treated with autologous or allogeneic BMT after identical induction, consolidation, and conditioning regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and risk group (high vs standard).
Induction
- Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma with more than 30% blasts in bone marrow
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Bilirubin less than 2 mg/dL (unless elevation due to leukemic involvement of liver)
- •Creatinine less than 2 mg/dL (unless elevation due to leukemic involvement of kidneys)
- •Cardiovascular:
- •No severe cardiac disease
- •No severe pulmonary disease
- •No severe neurologic or metabolic disease
- •HIV negative (if tested)
- •No other prior malignancy except nonmelanomatous skin cancer, stage I cervical carcinoma, or other curatively treated malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •No prior endocrine therapy
- •Radiotherapy:
- •No prior radiotherapy
- •No prior surgery
排除标准
- 未提供
研究者
研究点 (87)
Loading locations...
相似试验
已完成
3 期
Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00017602Genta Incorporated
已完成
3 期
S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple MyelomaPlasma Cell NeoplasmMultiple MyelomaNCT00064038SWOG Cancer Research Network198
终止
3 期
S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple MyelomaMultiple MyelomaNCT00005834SWOG Cancer Research Network19
已完成
2 期
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00021359Fox Chase Cancer Center17
已完成
3 期
Docetaxel in Treating Patients With Metastatic Breast CancerBreast CancerNCT00008411M.D. Anderson Cancer Center90