Efficacy and feasibility of first-line treatment with risk-adapteddose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkittlymphoma. A phase II clinical trial. - DA-EPOCH-R trial

VU University Medical Center0 个研究点开始时间: 2012年8月6日最近更新: 2012年11月5日

适应症

试验速览

暂无简介。

•First diagnosis of Burkitt lymphoma, histological confirmed according to the WHO classification 2008
•Age 18 -75 years.
•No prior treatment except local radiation or short course steroids 1 mg/kg for acute symptoms.
•All disease stages.
•HIV negative or positive.
•ECOG-WHO status 0-3; ECOG-WHO status 4 is allowed if BL related.
•Written informed consent obtained according to local guidelines.
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Inadequate renal function or creatinine clearance < 50 ml/min unless lymphoma related.
•Inadequate hepatic function: bilirubin > 2 * ULN (total) except patients with Gilbert’s syndrome as defined by > 80% unconjugated.
•Inadequate hematological function ANC < 1x109/l and platelets < 75x109 /l unless lymphoma related.
•Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with
•spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.
•Female subject pregnant or breast-feeding.
•Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion.
•History of a prior invasive malignancy in past 5 years.
•Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If echo is obtained the LVEF should exceed 40%.
•Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.
•HIV positive patients not willing to suspend HAART therapy during the treatment period of the protocol.

发起方

VU University Medical Center