A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 16
- 主要终点
- Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow transplant using stem cells from a brother or sister that closely match the patient's stem cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. Giving methotrexate and cyclosporine before and after transplant may stop this from happening. It is not yet known whether a donor peripheral stem cell transplant is more effective than a donor bone marrow transplant in treating hematologic cancers or other diseases.
PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
详细描述
OBJECTIVES:
Primary
- Compare the time to treatment failure in patients with hematologic malignancies or other diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow transplantation.
Secondary
- Compare the hematological recovery and overall survival of patients treated with these regimens.
- Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in patients treated with these regimens.
- Compare the economic impact associated with these treatment regimens.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of one of the following hematologic malignancies:
- •Acute myeloid leukemia in first complete remission or second complete remission
- •Chronic myeloid leukemia in chronic or accelerated phase
- •Myelodysplasia, including any of the following:
- •Refractory anemia (RA)
- •RA with ringed sideroblasts
- •RA with excess blasts (RAEB) I
- •RAEB in transformation
- •Chronic myelomonocytic leukemia
- •Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:
- •Indolent non-Hodgkin's lymphoma (NHL)
- •Aggressive NHL
- •Chronic lymphocytic leukemia
- •Hodgkin's lymphoma
- •Myelofibrosis
- •Hematologic malignancy not otherwise specified
- •HLA-matched sibling donor available meeting all of the following criteria:
- •6/6 HLA match
- •HLA typing performed by serologic or DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
- •Not identical twin with patient
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No cognitive, linguistic, or emotional difficulty that would preclude participation in the quality-of-life component of the study
- •Able to communicate in English or French
- •No HIV antibody positivity
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.
干预措施: peripheral blood stem cell transplantation (Procedure)
Arm II
Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.
干预措施: allogeneic bone marrow transplantation (Procedure)
Arm II
Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.
干预措施: filgrastim (Biological)
Arm I
Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.
干预措施: filgrastim (Biological)
结局指标
主要结局
Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)
次要结局
- Detailed donor and patient self-reported outcomes
- Chronic GVHD details
- Cost
- Quality of life
- Primary graft failure
- Time to acute GVHD
- Time to neutrophil recovery
- Overall survival
- Time to chronic GVHD