Burkitt lymphoma MedDRA version: 14.1 Level: HLT Classification code 10006596 Term: Burkitt's lymphomas System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Etoposide
Product Name: Etoposide
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ETOPOSIDE
CAS Number: 33419-42-0
Trade Name: Doxorubicin
Product Name: do
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • Inadequate renal function or creatinine clearance 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years. • Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an outpatient-clinic basis;Secondary Objective: • Assess predictive value of early FDG-PET/CT scans on PFS in BL.;Primary end point(s): • 2 years overall survival (OS; time from registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive) and progression free survival (PFS; i.e. time from registration to progression or death from any cause, whichever comes first). • Number of cycles of the DA-EPOCH-R scheme completed on an out-patient –clinic basis;Timepoint(s) of evaluation of this end point: Concerning OS and PFS, a sufficient number of events will have occurred 2 years after end of the recruitment period which is expected to take about 3 years. Concerning the number of cycles evaluation will take place 18 weeks after last patient included. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R on OS and PFS;Timepoint(s) of evaluation of this end point: Concerning the predictive value of PET/CTscan after 2 cycles, a sufficient number of events will have occurred 2 years after end of the recruitment period which is expected to take about 3 years. | — |
Countries
Netherlands
Contacts
Public ContactTrialoffice Hematology
VU University Medical Center
Outcome results
None listed