临床试验/NCT00843947

NCT00843947已完成2 期

Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan

University of California, Davis2 个研究点分布在 1 个国家目标入组 8 人开始时间: 2007年6月最近更新: 2017年6月27日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: University of California, Davis
入组人数: 8
试验地点: 2
主要终点: To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Phase II trial designed to evaluate the efficacy and toxicity of RIST, conditioned with fludarabine and busulfan, using G-CSF mobilized PBSC from an HLA-matched sibling or an unrelated volunteer donor. The primary endpoint of this study is day 100 TRM (Treatment Related Mortality). Secondary endpoints include response, engraftment times, acute and chronic GVHD, chimerism, toxicities, progression-free survival and overall survival.

Objectives

To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™).
To evaluate progression-free survival and overall survival.
To determine donor chimerism.
To assess the risk of acute and chronic graft versus host disease (GVHD).

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

•• Diagnosed with (any of the following)
•Disease Subtype Disease Status Leukemia Acute myelogenous leukemia (AML) Recurrent disease in remission* OR CR1 with poor-risk cytogenetics, antecedent hematological disease (i.e. myelodysplasia) or treatment-related leukemia Acute lymphoblastic leukemia (ALL) Recurrent disease in remission* OR CR1 with Philadelphia chromosome or poor risk cytogenetics Chronic myelogenous leukemia (CML) First or second chronic phase. There must be documented disease progression after imatinib mesylate (Gleevec) therapy OR documented lack of cytogenetic response 6 months post-imatinib initiation OR imatinib intolerance.
•Patient - Inclusion criteria (Continued) Chronic lymphocytic leukemia (CLL) Recurrent disease after fludarabine-based therapy. Patients must have chemosensitive** disease at the time of relapse.
•Lymphoma Recurrent Hodgkin's Lymphoma
•Recurrent Non-Hodgkin's lymphoma (NHL) (Low, intermediate or high grade)
•Transformed NHL Patients must have had prior autologous transplantation and received cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
•Patient with relapsed disease and required >2 salvage regimens to achieve CR or CRu.
•Multiple Myeloma Recurrent Myeloma Patients must have had prior autologous transplantation and demonstrate chemosensitivity** at the time of relapse Myelodysplastic Syndrome # RA/RARS RCMD/RCMD-RS RAEB-1 Patients must be transfusion-dependent and have International prostate symptom score (IPSS) of 1.5 or higher Advanced myeloproliferative disease Myelofibrosis with myeloid metaplasia; primary or evolved from other MPD Patient must be transfusion dependent or have evidence of progressive organomegaly or evidence of myelodysplasia
•remission is defined as morphological remission with bone marrow aspirate/biopsy showing <= 5% blasts within 4 weeks before the start of therapy. (Cytogenetic or molecular remission is not required)
•In CLL, chemosensitivity is defined as greater than 50% reduction of wbc and lymphadenopathy. In MM, it is defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration.
•based on WHO classification system. Patients with RAEB-2 or del(5q) are excluded
•5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor
•Age > 50 OR age 18-50, but have preexisting medical conditions, or have received prior therapy (i.e. prior) autologous transplantation) and are considered to be a too high a risk for conventional myeloablative transplantation

排除标准

•• Karnofsky performance status of less than 50%
•Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
•Corrected pulmonary-diffusing capacity of less than 35%
•A cardiac ejection fraction of less than 30%
•A serologic evidence of infection with the human immunodeficiency virus
•Inability to give informed consent
•Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
•Decompensated liver disease with serum bilirubin > 2.0 mg/dl
•Serum creatinine > 2.0 mg/dl
•Uncontrolled active infection
•Uncontrolled CNS metastasis

结局指标

主要结局

To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™)

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方

University of California, Davis

申办方类型

Other

责任方

Sponsor

研究点 (2)

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