Diffuse large B cell lymphoma, DLBCL, BCL-U, MYC
Conditions
Interventions
Eligible patients will receive lenalidomide 15 mg on day 1-14 in addition to standard therapy with R-CHOP.
Sponsors
HOVON
Eligibility
Inclusion criteria
Inclusion criteria: * DLBCL or BCL-U, histologically confirmed according to the WHO classification 2008 with a MYC rearrangement as determined by FISH comprising: - single hit (SH MYC+ lymphoma, not fulfilling the criteria for Burkitt Lymphoma ) or - double hit lymphoma (DH) MYC+/BCL2+ or MYC+/BCL6+ or - triple hit lymphoma (TH)MYC+/BCL2+/BCL6+ * Age ¡Ý 18 year * No prior treatment except - local radiation or short course (max 7 days) steroids (max 100 mg/day) - 1 course of R-CHOP in case MYC positivity became evident during first cycle of treatment * WHO performance status (PS) 0-3, status 4 only if disease related (see appendix C) * Ann Arbor stage II-IV * Measurable disease: on CT scan at least 1 lesions/node with a long axis of >1.5 cm and at least one positive lesion on 18F-FDG PET scan. * Negative pregnancy test at study entry * Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Risk Management Program * Written informed consent * Patient is capable of giving informed consent
Exclusion criteria
Exclusion criteria: * All histopathological diagnoses other than DLBCL or BCL-U according to the WHO classification 2008, like Burkitt lymphoma, irrespective of the presence of MYC rearrangement * Known history of indolent lymphoma. If during screening localization of an indolent lymphoma in the bone marrow biopsy is diagnosed, the patient is eligible. * Inadequate renal function or creatinine clearance 3 times ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin * Inadequate hematological function: ANC < 1.0x109/L or platelets < 75x109 /L unless lymphoma related * CNS localization of the lymphoma * Female subject pregnant or breast-feeding * History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma * Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If echo or MUGA is obtained the LVEF should exceed 40% * Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) that would jeopardize the patient's ability to receive the regimen with reasonable safety * HIV positivity * Active Hepatitis B or C infection as defined by positive serology and transaminitis. Non-active Hepatitis B carriers may be included if protected with lamivudine (see 9.4 of protocol) * Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D of protocol) * Severe neurological or psychiatric disease * Current participation in another clinical trial interfering with this trial * Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Claustrophobia to the extent that PET-CT is impossible
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| *Event Free Survival (EFS), defined as time from registration until no CR on protocol, relapse or death from any cause, whichever comes first * Overall survival (OS), calculated from registration until death from any cause. Patients still alive or lost to follow up are censored at the last date known to be alive. * Disease free survival (DFS) from time of complete remission. DFS is defined as duration from start of CR to relapse or death from any cause, whichever comes first, and applies only to patients who achieved CR. * The relationship between mid-treatment 18F-FDG PET-CT result and end-of-treatment 18F-FDG PET-CT result. | — |
Primary
| Measure | Time frame |
|---|---|
| * Complete remission rate as determined by - end-of-treatment PET-CT scan - end-of-treatment negative bone marrow examination in case of localization of DLBCL or BLC-U at diagnosis For complete remission, patients should have been treated with ¡Ý 3 cycles of R2CHOP. If the patient was in CR at mid-treatment PET-CT, but has to go off protocol after cycle 4 or 5 because of toxicity, end-of-treatment PET-CT has to show CR. | — |
Contacts
Public ContactM.E.D. Chamuleau
VU University Medical Center Dpt of Hematology De Boelelaan 1117
Outcome results
None listed