A Phase II Study to Evaluate the Efficacy of Oral Beclomethasone Dipropionate for Prevention of Acute GVHD After Hematopoietic Cell Transplantation With Myeloablative Conditioning Regimens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment
研究概览
简要总结
RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer.
PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.
详细描述
PRIMARY OBJECTIVES:
I. Assess the efficacy of oral BDP for prevention of acute GVHD after allogeneic hematopoietic cell transplantation with myeloablative conditioning regimens.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: beclomethasone dipropionate (Drug)
Arm I
Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: tacrolimus (Drug)
Arm I
Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: methotrexate (Drug)
Arm I
Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
Arm II
Patients receive oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: placebo (Drug)
Arm II
Patients receive oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: tacrolimus (Drug)
Arm II
Patients receive oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: methotrexate (Drug)
Arm II
Patients receive oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment
时间窗: On or before day 90 after the transplant
次要结局
- Cumulative glucocorticoid dose (measured as prednisone equivalents) per kg body weight(First 75 days after HCT)
- Peak and average skin, liver and gut morbidity stages and overall grades(To day 90 after HCT)
- Modified average acute GVHD index score(To day 90 after HCT)
- Cumulative incidence of biopsy-proven gastrointestinal GVHD(On or before day 90 after the transplant)
- Feasibility(First 75 days after HCT)
- Cumulative incidence of topical therapy for acute GVHD, including psoralen and UV irradiation, hydrocortisone cream, topical tacrolimus, oral BDP, or oral swish and spit dexamethasone(On or before day 90 after the transplant)
- Number of days in the hospital(During the first 90 days after HCT)
- Non-relapse mortality(At any time after HCT)
- Overall survival(At any time after HCT)
- Proportions of patients with grades IIa and IIb - IV GVHD(On or before day 90 after the transplant)
- Safety(On or before day 90 after the transplant)
- Cumulative incidence of systemic immunosuppressive treatment for acute GVHD(At any time after HCT)
- Proportion of patients with grade IIa GVHD(On or before day 90 after the transplant)
- Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment(At any time after HCT)
- Survival(At 200 days after HCT)
- Survival without recurrent malignancy(At any time after HCT)