Infusion of Expanded Cord Blood T Cells Following Cord Blood Transplantation

M.D. Anderson Cancer Center0 个研究点开始时间: 2009年9月最近更新: 2012年10月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: M.D. Anderson Cancer Center
主要终点: Maximum Tolerated Dose (MTD)

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 treating umbilical cord blood with growth factors before a transplant can help to improve the body's ability to accept the cord blood transplants.

详细描述

Umbilical cord blood is a source of stem cells that can be used for transplantation. The major problem with this type of transplant is the small number of stem cells that are available in the cord blood. This delays the recipients body's ability to accept the cord blood. This may also cause the immune system to slow, making infection more likely. One method to help fix this problem is to treat a sample of the cord blood with growth factors, which may promote the growth of the needed T cells before they are given to the recipient as a transplant.

For this study, participants will receive high-dose chemotherapy, then an untreated cord blood cells transplant, and then 14 days later receive the treated cord blood cells transplant.

The Study Drugs:

Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Thiotepa is designed to the damage DNA, which may cause cancer cells to die

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 55 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient must have one of the following hematologic malignancies:
•CLL (Select from Criteria #2 through #7)
•Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS; Myelodysplastic syndromes with International Prognostic Scoring System score >2 or myelodysplasia that has not responded to chemotherapy): induction failure, high-risk for relapse 1st remission (with high-risk cytogenetics or FLT3 mutation), 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.
•Acute Lymphoblastic Leukemia (ALL): induction failure, 1st complete remission with Philadelphia chromosome or translocation, 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.
•Chronic Myelogenous Leukemia (CML) second chronic phase, accelerated phase or blast crisis with less than 10% blasts in the bone marrow and/or peripheral blood and failure of at least one tyrosine kinase inhibitor.
•Non-Hodgkin's Lymphoma (NHL): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).
•Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).
•Chronic Lymphocytic Leukemia (CLL): Failure of one multi-agent regimen including fludarabine or other nucleoside analog
•Patient's Age Criteria: Age >/= 6 months and </= 55 years
•Performance score of < 3 (Zubrod score).
•Adequate major organ system function as demonstrated by: (SEE CRITERIA #11 through #14)
•Left ventricular ejection function of >/= 50%.
•Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. If unable to perform pulmonary function test (most children <6 years of age), pulse oximetry >/= 92% on room air.
•Creatinine </= 1.6 mg/dL in adults and </=2 times upper limit of normal in pediatric patients.
•SGPT/bilirubin </= 3.0 x normal.
•Signed informed consent.
•Negative Beta HCG or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study.
•Cord Blood Requirements: Unrelated CB will be used as a source of hematopoietic support if a 5/6 or 6/6 related or 6/6 unrelated bone marrow donor is not available, or if the tempo of the patient's disease dictates it is not in the patient's best interest to wait for an unrelated marrow donor to be procured. The back up cord blood unit must match at 4 of 6 HLA.
•An unrelated donor, second cord blood transplant, or autologous stem cells harvested prior to high-dose chemotherapy will be used in the event of graft failure. Based on the health status of the patient, autologous harvest may or may not occur. To be determined by the treating physician. The cord blood unit will be identified prior to enrollment in this study.

排除标准

•HIV positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
•Patient with active (untreated) CNS disease
•Availability of an appropriate, willing, HLA-matched related marrow donor
•Active invasive infections.
•Pregnant or breast-feeding