Mantle Cell Lymphoma
Conditions
Keywords
mantle cell lymphoma, EDOCH, DHAP, maintenance therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGEtoposide
50 mg/m2, IV d1-4
DRUGDoxorubicin
10 mg/m2, IV, d1-4
DRUGDexamethasone
30 mg/d, d1-5
DRUGVincristine
0.4 mg/m2, IV, d1-4
DRUGCyclophosphamide
750 mg/m2 ,d5
DRUGCytarabine
2g/m2, q12h, d1
DRUGCisplatin
100mg/ m2,IV, d1
DRUGRituximab
375 mg/m2 IV, d1
DRUGThalidomide
50-150mg/d, po, d1-28
DRUGPrednisone
0.5mg/Kg, po, qod
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | up to 36 months | the time interval between diagnosis and disease progression or death or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission | up to 6 months | measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs |
| overall survival | up to 36 months | time interval between diagnosis and death or last follow-up |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShuhua Yi, Doc
Blood disease hospital, Chinese Academic Medical School
Outcome results
None listed