跳至主要内容
临床试验/NCT00772811
NCT00772811已完成2 期

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Cooperative Study Group A for Hematology1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2001年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)

研究概览

简要总结

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

详细描述

Treatment plan

  • Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.
  • Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
  • Melphalan will be administered following the completion of Fludarabine infusion at day -2.
  • In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2.
  • Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours.
  • 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.
  • Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed.
  • GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.

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
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must be 15 years of age or older and 65 years of age or younger
  • Patients with CLL, lymphoma, or multiple myeloma will be included in this study
  • No prior anti-cancer treatment should be done within 30 days.
  • Informed consent should be given.
  • Patients should have an HLA-identical or single HLA-locus mismatched donor.
  • Karnofsky performance scale should be 50 or over (see Appendix I).

排除标准

  • Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.
  • Patients with high serum creatinine level will be excluded.
  • Patients should have uncontrolled infection.
  • No major anticipated illness or organ failure incompatible with survival from stem cell transplant.
  • Serum bilirubin less than or equal to 4.0 mg/dL.

研究组 & 干预措施

Flu-Mel

No Intervention

Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.

干预措施: Flu-Mel (Drug)

结局指标

主要结局

To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)

时间窗: 9years

-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.

次要结局

  • include tumor response, incidence of chronic GVHD, and immune reconstitution.(9years)

研究者

发起方
Cooperative Study Group A for Hematology
申办方类型
Network

研究点 (1)

Loading locations...

相似试验