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.

Phase 2

Completed

• Conditions: Burkitt lymphoma; highly aggressive B cell lymphoma; 10025320

• Registration Number: NL-OMON36941
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

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.
* HIV positive patients not willing to suspend HAART therapy during the treatment period of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br>-2 years overall survival (OS; time from registration. Patients still alive or<br /><br>lost to follow up are censored at the date they were last known to be alive)<br /><br>and progression free survival (PFS; i.e. time from registration to progression<br /><br>or death from any cause, whichever comes first).<br /><br>-Number of cycles of the DA-EPOCH-R scheme completed on an out-patient *clinic<br /><br>basis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint<br /><br>-Negative predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R<br /><br>on OS and PFS</p><br>