EUCTR2012-002761-35-IT进行中（未招募）不适用
Trattamento di prima linea della Leucemia Linfoblastica Acuta (LLA) Philadelphia positiva (Ph+)/BCR/ABL+ con un nuovo potente inibitore delle Tirosin-chinasi (TKI), AP24534 (Ponatinib). Studio multicentrico, esplorativo, di fase II in pazienti di et? superiore ai 60 anni o non idonei al programma intensivo di chemioterapia e trapianto delle cellule staminali.
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点开始时间: 2012年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. To be classified as having Ph+ ALL, patients must have >20% blasts in bone marrow at the time of diagnosis and no prior history of CML. 2. Patients with previously untreated Ph+ and/or BCR/ABL + ALL: - age = 60 years old or - age = 18 years old, but unfit for program of intensive therapy and allogeneic SCT 3. Signed written informed const according to ICH/EU/GCP and national local laws. 4. Effective contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Uncontrolled congestive heart failure or/and uncontrolled hypertension. 2. History of myocardial infarction within 3 months, or uncontrolled angina pectoris. 3. Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula) . 4. WHO performance status = 50% (Karnofsky) or = 3 (ECOG). 5. Active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN. 6. Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day. 7. History of acute pancreatitis within 1 year of study, or history of chronic pancreatitis, history of alcohol abuse; ongoing or active infection; uncontrolled hypertriglyceridemia (triglicerides > 450 mg/dL). 8. Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., severe malabsorption syndrome, or extended small bowel resection). 9. Patients who are currently receiving treatment with any of the medications listed in Appendix D if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix D have the potential to prolong QT. 10. Patients who have received any investigational drug = 4 weeks. 11. Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 12. Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Ponatinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs. 13. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 14. Patients unwilling or unable to comply with the protocol.
研究者
相似试验
进行中（未招募）
不适用
Tratamiento de primera línea del linfoma difuso de célula grande B (LDCGB) con quimioterapia a dosis densas e inmunoterapia (R-CHOP/14) en pacientes mayores de 65 años, y en menores de 65 años de riesgo bajoFirst-line treatment of diffuse large B-cell lymphoma (DLBCL) with dose-dense chemotherpahy and immunotherapy (R-CHOP/14) in patients older than 65 years and in low-risk patients younger than 65 years - R-CHOP/14infoma difuso de célula grande B (LDCGB)Diffuse large B-cell lymphoma (DLBCL)EUCTR2005-005110-20-ESGEL/TAMO (Grupo Cooperativo Español de Linfoma/Transplante Antólogo de Médula Ósea)
进行中（未招募）
不适用
Traitement de première ligne des lymphomes du manteau de patients agés de 65 à 80 ans. Evaluation de l'efficacité, de la toxicité et de facteurs pronostiques moléculaires de l'inhibiteur du protéasome ( PS341-Velcade) associé à une chimiothérapie et une immunothérapie par rituximab ( schéma RiPAD + C) - MANTEAU 2006 SAEUCTR2006-004768-30-FRGOELAMS
进行中（未招募）
不适用
Traitement des leucémies primitives à plasmocytes du sujets de moins de 70 ansEUCTR2009-016607-33-FRCHU Amiens
招募中
3 期
Acute Lymphoblastic Leukemia treatment protocol for children and adolescentRBR-6pmfz8Sociedade Brasileira de Oncologia Pediátrica (SOBOPE)
进行中（未招募）
不适用
A phase III trial to assess ibrutinib plus rituximab against FCR in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL)Chronic Lymphocytic Leukaemia (CLL).MedDRA version: 17.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001944-76-GBniversity of Leeds754