Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- assess cGVHD-free survival
研究概览
简要总结
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18- years-old at time of consent
- •Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
- •Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- •Karnofsky score ≥ 70%
- •Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
- •°Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: *Intrauterine device (IUD) plus one barrier method *Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method *2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or * A vasectomized partner.
- •For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
排除标准
- •Recipient of CD34+ selected or engineered stem cell graft
- •Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- •Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
- •Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
- •Use of investigational agent within 14 days pre-HCT
- •Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- •Uncontrolled psychiatric illness
- •Female patient who is pregnant or breastfeeding
- •Known allergy or sensitivity to ruxolitinib
研究组 & 干预措施
An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
干预措施: Cyclophosphamide (Drug)
An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
干预措施: Mycophenolate Mofetil (Drug)
An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
干预措施: Ruxolitinib (Drug)
An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
干预措施: Tacrolimus (Drug)
A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
干预措施: Cyclophosphamide (Drug)
A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
干预措施: Mycophenolate Mofetil (Drug)
A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
干预措施: Tacrolimus (Drug)
结局指标
主要结局
assess cGVHD-free survival
时间窗: 1 year post-HCT
Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.
次要结局
- incidence of grade 2-4 infections.(1 year)