ISRCTN44728648已完成不适用

Multicenter, non-randomised Phase II pilot study to assess the efficacy and safety of dasatinib after allogeneic stem cell transplantation in patients with de novo Philadelphia positive (bcr-abl +) acute lymphoblastic leukemia

Spanish Group of Hematopoietic Transplantation and Cell Therapy (GETH) (Spain)0 个研究点目标入组 30 人开始时间: 2010年11月4日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Adult patients = 18 years
•2. Diagnostic confirmation of de novo Ph+ (BCL-ABL translocation) ALL
•3. Patients in first/second complete remission (CR) (assessed by cytology, karyotyping, fluorescent in-situ hybridisation [FISH] and BCR/ABL reverse transcriptase- polymerase chain reaction [RT-PCR]) at transplantation
•4. Patients with sustained hematologic and cytogenetic CR at the time of study entry
•5. Any modality of allogeneic SCT
•6. Patients are in day +180 (± 2 weeks) after allogeneic SCT with stable graft (patients may sign inform consent from day +166 on, but will not start study treatment until they have reached day +180 and not later than day + 194)
•7. Ability to understand and voluntarily sign the informed consent form
•8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start

•1. Patients with Eastern Cooperative Oncology Group (ECOG) 3-4 at study entry
•2. Any of the following laboratory abnormalities:
•2.1. Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l
•2.2. Serum creatinine > 2.0 mg/dl (177 mmol/l)
•2.3. Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate piruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN)
•2.4. Total bilirrubin > 3 mg/dl
•3. Known HIV infection or any other uncontrolled infection at study entry
•4. Known pleural effusion of any grade at study entry
•5. Morphologic or cytogenetic or molecular relapse at study entry
•6. Evidence of digestive dysfunction that could prevent administration of study therapy
•7. Prior therapy with dasatinib
•8. Other concurrent malignancy at study entry
•9. Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias
•10. Any psychiatric condition that could prevent patient from signing the informed consent or could put the patient at an unacceptable risk in case of participating in the trial
•11. Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed.

发起方

Spanish Group of Hematopoietic Transplantation and Cell Therapy (GETH) (Spain)