NCT07006506招募中2 期
Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 15
- 主要终点
- Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
研究概览
简要总结
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.
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
- 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 who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).
- •Recipients of 7-8/8 related or unrelated HLA-matched or related haploidentical donor.
- •Peripheral blood stem cell graft
- •Allo-HCT day <120 at time of consent
- •Post-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)
- •Patient has received an allo-HCT transplant and is 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.
- •Patient has achieved engraftment. Engraftment is defined as ANC≥500/μL and platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.
- •Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.
- •Karnofsky score ≥ 70%.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
- •Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).
- •Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
- •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 study drug. Effective birth control includes: * Intrauterine device (IUD) plus one barrier method * Stable doses of hormonal contraception for at least 3 months (eg, 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).
- •Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- •Pulmonary dysfunction with DLCO <50% corrected for hemoglobin
- •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.
- •Post-HCT exclusion criteria
- •Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.
- •Use of investigational agent within 14 days pre-HCT or anytime thereafter.
- •Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).
- •Active treatment with corticosteroids at a dose of ≥ 0.25 mg/kg/day for non-GVHD indication.
- •Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
- •Female patient who is pregnant or breastfeeding.
- •Prior therapy with belumosudil.
- •Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.
研究组 & 干预措施
Participants with hematologic malignancy in morphologic remission
Experimental
Participants will be diagnosed with a hematologic malignancy in morphologic remission
干预措施: Belumosudil (Drug)
结局指标
主要结局
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
时间窗: 1 year
The primary objective is to assess the efficacy of belumosudil in the improvement of GRFS at 1-year post-HCT for patients receiving PTCY GVHD prophylaxis and separately for participants receiving CNI-based (CNI without PTCY) plus abatacept GVHD prophylaxis.
次要结局
未报告次要终点
研究者
研究点 (15)
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