A phase II study evaluating the effect of the addition of lenalidomide to R-CHOP for patients with newly diagnosed MYC positive DLBCL and BCL-U.
Recruiting
- Conditions
- Diffuse large B cell lymphoma, DLBCL, BCL-U, MYC
- Registration Number
- NL-OMON24704
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * Complete remission rate as determined by<br /><br>- end-of-treatment PET-CT scan<br /><br>- end-of-treatment negative bone marrow examination in case of localization of DLBCL or BLC-U at diagnosis<br /><br /><br><br>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.
- Secondary Outcome Measures
Name Time Method *Event Free Survival (EFS), defined as time from registration until no CR on protocol, relapse or death from any cause, whichever comes first<br /><br>* 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.<br /><br>* 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.<br /><br>* The relationship between mid-treatment 18F-FDG PET-CT result and end-of-treatment 18F-FDG PET-CT result.