Phase I/II trial of dexamethasone, ofatumumab and bendamustine [Treanda] (DOT) as first-line treatment of mantle-cell lymphoma (MCL) in the elderly - DOT in elderly MCL patients

ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2009年11月2日最近更新: 2013年12月9日

适应症

试验速览

暂无简介。

•Age ≥ 60 years. ECOG Performance Status 0-1. Life expectancy of at least 6 months. Histological diagnosis of MCL (morphology, CD5+ /CD20+ /CD23-, t(11:14) and/or cyclin D1 overexpression). disease requiring treatment (patients with bone marrow only disease, who are candidates for a watch-and-wait approach, will be sxcluded) Adequate bone marrow, liver and renal function, unless the abnormality is related to the tumor and is unlikely to affect the safety of bendamustine and ofatumumab use. Adequate marrow and organ function will be assessed by the following laboratory requirements to be conducted within 7 days prior to screening:Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1000/?l;Platelet count ≥ 75000/?l; Total bilirubin ≤ 1.5 times the ULN; AST and ALT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 4 x ULN; Serum creatinine ≤ 2.5 x ULN; PT-INR/PTT < 1.5 x ULN. No prior therapy. Written informed consent
•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

•Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert`s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment). History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. History of HIV infection or active chronic hepatitis B or C. Active clinically serious infections (> grade 2 NCI-CTC version 3.0). History of organ allograft. Patients with evidence or history of bleeding diathesis. Patients undergoing renal dyalisis. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, trated basal cell carcinoma, superficial bladder tumor or any cancer curatively treated > 3 years prior to study entry. Substance abuse, medical psychological or social conditions that may interfere with the patient s participation in the study or evaluation of the study results. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

发起方

ISTITUTO NAZIONALE PER LA CURA TUMORI