NL-OMON36941
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Burkitt lymphoma
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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.
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.
Outcomes
Primary Outcomes
Not specified
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