A trial to investigate treatment with EPOCH-R in patients with Burkitt lymphoma, by adapting the dose to the risk classification of the disease.

• Conditions: Burkitt lymphoma; MedDRA version: 14.1Level: HLTClassification code 10006596Term: Burkitt's lymphomasSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-003141-16-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-06
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified