NCT07358195尚未招募1 期
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient Inclusion Criteria:
- •Patient ages 18-70
- •Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.
- •Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.
- •Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
- •LVEF > 40% as measured by echocardiography or MUGA
- •FEV1, FVC, and DLCO > 50% of predicted as measured by standard PFTs
- •Total bilirubin < 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all < 5x institutions upper limit of normal
- •ABO compatibility in the host vs. graft direction
- •Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
- •Participants should be on dialysis or have a CrCl ≤ 35 ml/min
- •Life expectancy greater than 6 months
- •Recipient ability to understand and provide informed consent
- •Donor Inclusion Criteria:
- •HLA matched or haploidentical relative as defined by 3/6, 4/6, or 5/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
- •ECOG performance status 0 or 1
- •Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
- •Acceptable laboratory parameters (hematology in normal or near-normal range; liver function < 3 times the upper limit of normal and normal creatinine)
- •Compatible ABO blood group
- •Negative donor lymphocyte cross match
- •No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)
- •Donor ability to understand and provide informed consent
- •Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation
排除标准
- •Active serious infection
- •Participation in other investigational drug use at the time of enrollment
- •Positivity for active infection with HIV, HCV, or HBV
- •ABO blood group incompatibility in the host-vs-graft direction
研究者
Thomas Spitzer
Professor of Medicine, Harvard Medical School Director Emeritus, Bone Marrow Transplant Program
Massachusetts General Hospital
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