EUCTR2006-001853-89-DE进行中（未招募）不适用
A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
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
- •Inclusion Criteria
- •A.Patients must have pathologically confirmed AML, based upon the World Health Organization (WHO) criteria (Appendix A). Patients with acute promyelocytic leukemia (t(15;17)) will be excluded. Patients with favorable cytogenetics (t(15;17), t(8;21), or inv 16) will also be excluded.
- •B.Patients must be = 60 years old and have no prior history of chemotherapy with/without irradiation and no prior history of an antecedent hematologic history (MDS or myeloproliferative disease). In addition, patients must not have received a standard induction regimen containing cytotoxic agents (regimens containing araC or other nucleoside analogues +/- an anthracycline) nor a regimen containing a low-dose single agent cytotoxic chemotherapy (e.g., araC, decitabine, 5-azacytidine). Prior treatment with gemtuzumab ozogamycin is also excluded.
- •C.Patients must have at least one of the following documented poor risk features: •Unfavorable cytogenetics, defined as del (5q)/-5q; -7/del(7q); abnormal 3q, 9q, 11q, 20q, 21q or 17p; t(6; 9); t(9; 22); trisomy 8; complex karyotypes (> 3 unrelated abnormalities), or •ECOG Performance Status = 2 (Appendix B), or •Age > 70 years, or •Cardiac dysfunction which would limit the use of anthracycline therapy, as defined by any one of the following: (i)an ejection fraction < 50%, or (ii)a history of significant coronary artery disease (one or more vessel stenosis requiring medical treatment, stent placement or surgical bypass graft), or (iii)a history of congestive heart failure or myocardial infarction, or (iv)a significant arrhythmia including atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmia, or (v)heart valve disease (excluding mitral valve prolapse), or (vi)other heart disease (must be approved by the sponsor). Patients with a history of heart disease as defined above must be on appropriate medication(s) and have their disease under control. •Pulmonary dysfunction assumed not to be related to the patient’s AML, as defined by DLCO and/or FEV1 < 80% or dyspnea on slight activity or at rest, or requiring oxygen, or •Hepatic dysfunction related to (i) chronic hepatitis, or (ii) liver cirrhosis •Other organ dysfunction or comorbidity that precludes standard cytotoxic induction treatment, such as 3+7”, with sponsor approval
- •D.Patients must have the following clinical laboratory values within 24 hours prior to beginning protocol treatment: 1.Serum creatinine ? 2.0 mg/dl. 2.Total bilirubin ? 2.0 mg/dl. 3.Alanine aminotransferase (ALT/SGPT), or aspartate aminotransferase (AST/SGOT) ? 5x the upper limit of norma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •A.Patients with secondary AML. Secondary AML is defined as AML that has developed in a patient with a history of an antecedent hematologic disorder, MDS or a myeloproliferative disorder or a history of prior chemotherapy or radiation for a disease other than AML.
- •B.Uncontrolled active infection of any kind. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study. Patients with chronic hepatitis are eligible.
- •C.Patients with favorable cytogenetics including t(15;17), inv16, t(8;21) are excluded.
- •D.Patients with known central nervous system disease
- •E.Patients with ECOG Performance Status 3, or 4.
- •F.Patients concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea and leukophoresis.
- •G.Patients who have clinical evidence by physical exam, radiologic studies, or tissue biopsies of an ongoing second malignancy unrelated to AML or MDS.
- •H.Because the formulation contains 30% ethanol, patients being treated with disulfiram (Antabuse) are excluded from the study.
- •I.Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting Cloretazine® (VNP40101M).
- •J.Patients on the screening ECG who demonstrate left bundle branch block, use of an obligate cardiac pacemaker or atrial fibrillation will be excluded from the ECG substudy as will patients with diabetes mellitus treated with insulin
研究者
相似试验
进行中（未招募）
不适用
A phase II study of Cloretazine for elderly patients with de novo poor risk acute myelogenous leukemia.Acute Myelogenous LeukemiaEUCTR2006-001853-89-GBVion Pharmaceuticals, Inc85
尚未招募
3 期
A research study for patients with acute myeloid leukemia (AML) in first relapseCancer - Leukaemia - Acute leukaemiaAcute Myeloid LeukemiaACTRN12606000514505Vion Pharmaceuticals, Inc.420
进行中（未招募）
不适用
A Phase II Trial of Clofarabine in Older Patients with Acute Myeloid Leukaemia for Whom Intensive Chemotherapy is Not Considered SuitableMedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Acute Myeloid LeukemiaEUCTR2004-004527-35-ITBioenvision Limited
进行中（未招募）
1 期
A PHASE II TRIAL OF CLOFARABINE IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA FOR WHOM INTENSIVE CHEMOTHERAPY IS NOT CONSIDERED SUITABLEEUCTR2004-004527-35-IEBioenvision Limited65
招募中
2 期
Phase II study of R-mini CHP for elderly patients with diffuse large B cell lymphomadiffuse large B cell lymphomaJPRN-UMIN000011234Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)40