Primary objectives-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 out-…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints
-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
Secondary outcome
Secondary endpoint
-Negative predictive value of low dose PET/CT scan after 2 cycles of DA-EPOCH-R
on OS and PFS
Background summary
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 objective
Primary objectives
-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 out-patient-clinic basis
Secondary objective
-Assess negative predictive value of early FDG-PET/CT scans on PFS in BL.
Study design
Phase II, prospective, monocenter, open label, non-randomized clinical trial
of risk adapted DA-EPOCH-R in BL:
* Low risk patients will receive 3 cycles of DA-EPOCH-RR
* High risk patients will receive 6 cycles of DA-EPOCH-R
* CSF cytology will be done in all patients.
* High Risk patients with CSF negative will receive prophylactic intrathecal
treatment
* Low risk patients with CSF negative (1 normal LP and no clinical suspicion)
will not receive prophylactic intrathecal treatment
* All patients with CSF positive will receive active intrathecal treatment
* 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
* A total of 22 patients will be enrolled in the protocol.
Intervention
combination chemotherapy
Study burden and risks
The chemotherapy will be given by a portable pump system. Once a day, the
patient is requested to visit the hospital for changing the bag.
For the patient is this less demanding than a hospital admission.
For the ward, its beneficial for the bed setting.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-003141-16-NL |
| CCMO | NL41499.029.12 |
| Other | NTR |