Burkitt lymphoma, Burkitt Lymfoom
Conditions
Interventions
1. Low risk patients (3 cycles of Dose Adjusted EPOCH with 2xRituximab)
2. High risk patients (6 cycles of DA-EPOCH-Rituximab).
EPOCH is Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin.
Low risk patients with a positive PET-CTscan after 2 cycles of DA-
Sponsors
VU University Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. First diagnosis of Burkitt lymphoma, histological confirmed according to the WHO classification 2008; 2. Age ≥ 18 years; 3. No prior treatment except local radiation or short course steroids ≤ 1 mg/kg for acute symptoms; 4. All disease stages; 5. HIV negative or positive; 6. ECOG-WHO status 0-3, status 4 only if disease related; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. All histopathological diagnoses other than BL according to the WHO classification 2008, irrespective of the presence of MYC rearrangement; 2. Inadequate renal function or creatinine clearance 2 * ULN (total) except patients with Gilbert’s syndrome as defined by > 80% unconjugated; 4. Inadequate hematological function ANC 30% blasts in bone-marrow and/or peripheral blood, without significant lympadenopathy; 6. 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; 7. Female subject pregnant or breast-feeding; 8. Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion; 9. History of a prior invasive malignancy in past 5 years; 10. Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If echo is obtained the LVEF should exceed 40%; 11. Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety; 12. HIV positive patients not willing to suspend HAART therapy during the treatment period of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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); 2. Number of cycles of the DA-EPOCH-R scheme completed on an out-patient –clinic basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R on OS and PFS. | — |
Contacts
Public ContactM.E.D. Chamuleau
VU University Medical Center Dpt of Hematology De Boelelaan 1117
Outcome results
None listed