No registrations found.
ID
Source
Brief title
Health condition
Burkitt lymphoma, Burkitt Lymfoom
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Negative predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R on OS and PFS.
Background summary
Study phase: Phase II.
Patient population:
Patients with newly diagnosed Burkitt lymphoma ≥ 18years.
Study objective:
To asses efficacy (PFS and OS at 2 years) and feasibility (defined as number of cyles administered on an out-patient-clinic basis) of risk-adapted DA-EPOCH-R in patients with newly diagnosed Burkitt lymphoma
Study design:
A prospective, monocenter, open label, non-randomized clinical trial:
1. Low risk patients will receive 3 cycles of DA-EPOCH-RR;
2. High risk patients will receive 6 cycles of DA-EPOCH-R;
3. CSF cytology will be done in all patients;
4. High Risk patients with CSF negative will receive prophylactic intrathecal treatment;
5. Low risk patients with CSF negative (1 normal LP and no clinical suspicion) will not receive prophylactic intrathecal treatment;
6. All patients with CSF positive will receive active intrathecal treatment;
7. FDG-PET/CT pre- and post-cycle 2 in all patients. Low risk patients with positive low-dose PET/CT (positive defined as a score ≥ 3 according to Deauville criteria (appendix B1) after 2 cycles will receive 6 cycles of DA-EPOCH-R;
8. A total of 22 patients will be enrolled in the protocol.
Study objective
The DA-EPOCH-R regimen represents a major paradigm shift for the treatment of BL. Whereas standard treatment relies on dose density and intensity based on methotrexate and cytarabin to achieve adequate cell kill, DA-EPOCH-R relies on a pharmacodynamic based infusional schedule to improve the therapeutic index of chemotherapy. Based on the pilot results presented by Dunleavy at ICML 2011, DA-EPOCH- R appears to provide a high rate of cure with significantly lower treatment toxicity and tumor lysis syndrome compared to standard treatment. As such, DA-EPOCH-R may provide a major treatment advance in BL by lowering morbidity, mortality, and cost, while maintaining or possibly improving efficacy. The current protocol is aims to confirm the results obtained with DA-EPOCH-R in BL in Dutch general hematology practice, as this protocol has been conducted primarily by the NIH.
Study design
Total expected study duration is 5 years.
Study start (FPFV): Nov 2012;
Recruitment end (LPFV): Nov 2015;
Study end (LPLV): Nov 2017;
Completion of Clinical Study Report (CSR): June 2018;
Publication date: June 2018.
Intervention
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-EPOCH-RR will receive 4 cycles of DA-EPOCH-R.
Dpt of Hematology<br>
De Boelelaan 1117
M.E.D. Chamuleau
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442604
m.chamuleau@vumc.nl
Dpt of Hematology<br>
De Boelelaan 1117
M.E.D. Chamuleau
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442604
m.chamuleau@vumc.nl
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
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 < 50 ml/min unless lymphoma related;
3. Inadequate hepatic function: bilirubin > 2 * ULN (total) except patients with Gilbert’s syndrome as defined by > 80% unconjugated;
4. Inadequate hematological function ANC < 1x109/l and platelets < 75x109 /l unless lymphoma related;
5. leukemic Burkitt lymphoma, defined as >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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3585 |
| NTR-old | NTR3750 |
| Other | EudraCT : 2012-003141-16 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |