Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2008年12月最近更新: 2021年2月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: M.D. Anderson Cancer Center
入组人数: 24
试验地点: 1
主要终点: Number of Participants With Molecular Response

研究概览研究设计入排标准研究组 & 干预措施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

The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.

详细描述

Study Drug:

Azacitidine is designed to block genes in cancer cells that stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.

Study Drug Administration and Procedures before the Stem Cell Transplant:

If you are found to be eligible to take part in this study, you will be given chemotherapy before the transplant of donor cells. The chemotherapy is designed to kill leukemia cells and will also block your body's ability to reject the donor cells that will be given to you during the transplant. You will receive the chemotherapy on the days before the transplant. You will receive the transplant on Day 0.

This low-level test dose of busulfan is to check how fast busulfan is processed by your body and cleared from your blood. This information will help the doctor decide the dose of busulfan you will receive. You may receive the busulfan test dose as an outpatient during the week before you are admitted to the hospital or as an inpatient on Day -8 (8 days before your stem cell transplant).

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with age <= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
•Patients with age <= 75 with CML in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
•Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
•Age 18 to 75 years.
•Zubrod performance status <=
•Left ventricular ejection fraction => 40%.
•Pulmonary function test within the following parameters: forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) => 50% of expected, corrected for hemoglobin.
•Serum creatinine < 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min.
•Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
•Serum glutamate pyruvate transaminase (SGPT) <= 200 IU/L unless related to patient's malignancy.
•Patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
•Patients with age <75 years with CML in second or subsequent chronic phase.

排除标准

•Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
•Pleural/pericardial effusion or ascites estimated to be >1L.
•HIV-positive.
•Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
•Known or suspected hypersensitivity to azacitidine or mannitol.
•Patients with advanced malignant hepatic tumors.