EDOCH Alternating With DHAP for New Diagnosed Younger MCL

EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial

The purpose of this study is to:

1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);
2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Enrolled patients will receive EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±R /DHAP(cisplatin, cytarabine and dexamethasone) ±R alternating chemotherapy. If a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles EDOCH ±R /DHAP±R chemotherapy (based on patient's choice). Patients with less than partial remission (PR) response will quit this study. After treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. The determination of maintenance regimens is dependent on patients choices.

Inclusion Criteria:

• age≤65 years
• diagnosis with mantle cell lymphoma
• Ann Arbor stage II,III or IV
• ECOG≤1 or if ECOG≥2 but recover after pretreatment.

Exclusion Criteria:

• with centre neural system involvement
• serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
• HIV positive or active HBV infection or other uncontrolled systematic infection
• clinical central nervous dysfunction
• serious surgery within 30 days
• pregnancy or baby nursing period or un-contracepted child bearing period woman.