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

Vrije Universiteit Medisch Centrum0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•* First diagnosis of Burkitt lymphoma, histological confirmed according to the WHO classification 2008
•* Patients * 18 years of age.
•* No prior treatment except local radiation or short course steroids 1 mg/kg for acute symptoms.
•* All disease stages.
•* ECOG-WHO status 0-3; WHO status 4 will be allowed if Burkit Lymphoma related.
•* Written informed consent obtained according to local guidelines.

•* 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.

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