Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Patients Without GVHD at 100 Days
研究概览
简要总结
Primary Objective:
- To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation.
Secondary Objectives:
- To determine safety of escalating doses of pentostatin in combination with tacrolimus and methotrexate.
- To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%.
- To document blood levels of tacrolimus when combined with pentostatin.
详细描述
During the study, patients will have blood, urine, bone marrow, and X-ray exams done. These exams are done to monitor the results of the transplantation. Blood tests will be done daily while patients are hospitalized.
Patients in this study will receive chemotherapy and/or radiation to treat their malignancy and prevent graft rejection. This is given before the infusion of donor cells.
Patients with myeloid leukemias may receive busulfan by vein (IV) for 4 days and cyclophosphamide by vein for 2 days.
Patients with lymphoid malignancies may receive thiotepa by vein in one dose, cyclophosphamide by vein for 2 days, and irradiation for 4 days.
Other chemotherapy treatments may be used before donor cell infusion.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving allogeneic hematopoietic transplants from an unrelated donor or one antigen mismatched related donors.
- •Patients with AML, ALL, Hodgkin's disease, MDS (including CMML), CML in late chronic or accelerated phase or in blast crisis, and lymphoma in first or later relapses.
- •Patients must have bilirubin < 1.5 mg/dL, DLCO > 50% predicted, LVEF > 45% and performance status 0 or
- •Candidates must have a creatinine level < 1.5 mg/dL or a calculated creatinine clearance > 60 ml/min.
排除标准
- •HIV seropositivity
- •Uncontrolled infection
- •Candidates should not have received chemotherapy other than hydroxyurea or Gleevec for at least 3 weeks prior to treatment. Maintenance therapy with oral chemotherapy is acceptable. Treatment day is defined as transplant day +8, which is the date of first dose of pentostatin.
- •Diagnosis of myelofibrosis.
研究组 & 干预措施
No Pentostatin
Group 1: No Pentostatin
干预措施: Pentostatin (Drug)
No Pentostatin
Group 1: No Pentostatin
干预措施: Tacrolimus (Drug)
No Pentostatin
Group 1: No Pentostatin
干预措施: Methotrexate (Drug)
Pentostatin 0.5
Group 2: Pentostatin 0.5 mg/m^2
干预措施: Pentostatin (Drug)
Pentostatin 0.5
Group 2: Pentostatin 0.5 mg/m^2
干预措施: Tacrolimus (Drug)
Pentostatin 0.5
Group 2: Pentostatin 0.5 mg/m^2
干预措施: Methotrexate (Drug)
Pentostatin 1
Group 3: Pentostatin 1 mg/m^2
干预措施: Pentostatin (Drug)
Pentostatin 1
Group 3: Pentostatin 1 mg/m^2
干预措施: Tacrolimus (Drug)
Pentostatin 1
Group 3: Pentostatin 1 mg/m^2
干预措施: Methotrexate (Drug)
Pentostatin 1.5
Group 4: Pentostatin 1.5 mg/m^2
干预措施: Pentostatin (Drug)
Pentostatin 1.5
Group 4: Pentostatin 1.5 mg/m^2
干预措施: Tacrolimus (Drug)
Pentostatin 1.5
Group 4: Pentostatin 1.5 mg/m^2
干预措施: Methotrexate (Drug)
Pentostatin 2
Group 5: Pentostatin 2 mg/m^2
干预措施: Pentostatin (Drug)
Pentostatin 2
Group 5: Pentostatin 2 mg/m^2
干预措施: Tacrolimus (Drug)
Pentostatin 2
Group 5: Pentostatin 2 mg/m^2
干预措施: Methotrexate (Drug)
结局指标
主要结局
Number of Patients Without GVHD at 100 Days
时间窗: 100 days
The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.
次要结局
未报告次要终点