Mantle cell lymphoma Cancer Lymphoma
Conditions
Interventions
INDUCTION:
Three series of maxi-CHOP and Ara-C and two series of rituximab:
1. Maxi-CHOP:
1.1. Cyclophosphamide (CTX) 1200 mg/m^2 day one
1.2. Doxorubicin 75 mg/m^2 day one
1.3. Vincristine 2 mg to
Sponsors
Individual sponsor (Denmark)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival, assessed every four months the first two years, subsequently every six months until death or relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free and overall survival 2. Molecular remission duration 3. Tumour-cell free stem-cell products Assessed every four months the first two years, subsequently every six months until death or relapse. | — |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed