2nd Nordic Mantle-Cell Lymphoma protocol
- Conditions
- Mantle cell lymphomaCancerLymphoma
- Registration Number
- ISRCTN87866680
- Lead Sponsor
- Individual sponsor (Denmark)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Newly diagnosed patients fulfilling the diagnostic criteria of mantle cell lymphoma
2. Ann Arbor stage II - IV
3. 18 - 65 years of age, either sex
4. Have given informed consent
Any organ dysfunction or failure that may present a risk to the patient during any phase of protocol treatment:
1. Renal function decreased corresponding to P-creatinine and/or blood urea nitrogen (BUN) increased to 2 x upper normal limit, unless clearly explained by the lymphoma
2. Liver biochemistry abnormal (P-Bilirubin, alanine aminotransferase [ALAT] or alkaline phosphatase increased to 2 x upper normal limit) unless clearly explained by the lymphoma
3. Chronic infections including human immunodeficiency virus (HIV) and hepatitis B
4. Pregnancy or lactation: for women of the childbearing age at inclusion adequate anti-conception must be secured (P-pills, depot injection gestagen or intra-uterine device)
5. Other malignancy except skin (non-melanoma) or cervix carcinoma stage 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival, assessed every four months the first two years, subsequently every six months until death or relapse
- Secondary Outcome Measures
Name Time Method 1. Progression free and overall survival<br>2. Molecular remission duration<br>3. Tumour-cell free stem-cell products<br><br>Assessed every four months the first two years, subsequently every six months until death or relapse.