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van CCT (UK)

van CCT (UK)

A trial to investigate the efficacy and feasibility of treatment with dose adjusted EPOCH-R (DA-EPOCH-R), adapted to risk profile in patients with newly diagnosed Burkitt lymphoma.

- candidate number14096
- NTR NumberNTR3750
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-dec-2012
- Secondary IDs2012-003141-16 EudraCT
- Public TitleA trial to investigate the efficacy and feasibility of treatment with dose adjusted EPOCH-R (DA-EPOCH-R), adapted to risk profile in patients with newly diagnosed Burkitt lymphoma.
- Scientific TitleEfficacy 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.
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedBurkitt lymphoma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-nov-2017
- Target number of participants22
- Interventions1. 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.
- Primary outcome1. 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 outcomeNegative predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R on OS and PFS.
- TimepointsTotal 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.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD14-dec-2012 - 4-jan-2013

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