UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progressive Free Survival Post Transplant
研究概览
简要总结
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
详细描述
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II or III non-progressive disease Multiple Myeloma.
- •CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
- •≤ 70 years old.
- •Eligible and willing HLA matched related donor.
- •Bilirubin <2xULN.
- •ALT and AST <3xULN.
- •LVEF > 40%.
- •Creatinine Clearance >40mL/min.
- •Pulmonary function DLCO corrected to ≥ 70%.
- •Minimum performance score of 70%.
- •Platelet count >130 x103 micro L.
- •LDH ≤1.5xULN.
- •No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
- •No uncontrolled infections.
排除标准
- •Age >70 years old.
- •Performance status <70%.
- •Uncontrolled infections or is HIV positive
- •Prior malignancies that are felt to have a <80% probability of being cured.
- •Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
- •Prior Allograft
- •History of rapidly growing disease at diagnosis or at any progression or have MDS.
- •No eligible and willing HLA matched donor.
研究组 & 干预措施
Non Myeloablative Treatment
Non-myeloablative Transplant Conditioning Chemotherapy :
Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
干预措施: Fludarabine (Drug)
Non Myeloablative Treatment
Non-myeloablative Transplant Conditioning Chemotherapy :
Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
干预措施: Total Body Irradiation (Radiation)
Non Myeloablative Treatment
Non-myeloablative Transplant Conditioning Chemotherapy :
Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
干预措施: Infusion of Stem Cells (Other)
结局指标
主要结局
Progressive Free Survival Post Transplant
时间窗: 365 days post transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progression Free Survival Post Transplant
时间窗: 2 years post transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
次要结局
- Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant(Post transplant up to 100 days post transplant)
- Composite Incidence of Acute and Chronic Graft Versus Host Disease(Up to 100 days post transplant.)
- Non-relapse Treatment Related Mortality(Within 100 days post transplant)
研究者
Racquel Innis-Shelton, MD
Principal Investigator
University of Alabama at Birmingham