EDOCH Alternating With DHAP for New Diagnosed Younger MCL

Study Overview
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Brief Summary
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The purpose of this study is to: 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); determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Detailed Description
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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.

Official Title
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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

Conditions
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Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: Etoposide
* Drug: Doxorubicin
* Drug: Dexamethasone
* Drug: Vincristine
* Drug: Cyclophosphamide
* Drug: Cytarabine
* Drug: Cisplatin
* Drug: Rituximab
* Drug: Thalidomide
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoposide<br>50 mg/m2, IV, d1-4 | Drug: Etoposide<br>* 50 mg/m2, IV d1-4<br>* Other names: VP-16;|
| Experimental: Doxorubicin<br>10 mg/m2, IV, d1-4 | Drug: Doxorubicin<br>* 10 mg/m2, IV, d1-4<br>* Other names: adriamycin;|
| Experimental: Dexamethasone<br>30 mg/d, d1-5 | Drug: Dexamethasone<br>* 30 mg/d, d1-5<br>* Other names: Dex;|
| Experimental: Vincristine<br>0.4 mg/m2, IV, d1-4 | Drug: Vincristine<br>* 0.4 mg/m2, IV, d1-4<br>* Other names: VCR;|
| Experimental: Cyclophosphamide<br>750 mg/m2 ,d5 | Drug: Cyclophosphamide<br>* 750 mg/m2 ,d5<br>* Other names: CTX;|
| Experimental: Cytarabine<br>2g/m2, q12h, d1 | Drug: Cytarabine<br>* 2g/m2, q12h, d1<br>* Other names: Ara-c;|
| Experimental: Cisplatin<br>100mg/ m2,IV, d1 | Drug: Cisplatin<br>* 100mg/ m2,IV, d1<br>* Other names: DDP;|
| Experimental: Rituximab<br>375 mg/m2 IV, d1 | Drug: Rituximab<br>* 375 mg/m2 IV, d1<br>* Other names: R;|
| Experimental: Thalidomide<br>50-150mg/d, po, d1-28 | Drug: Thalidomide<br>* 50-150mg/d, po, d1-28<br>* Other names: Thal;|
| Experimental: Prednisone<br>0.5mg/Kg, po, qod | Drug: Prednisone<br>* 0.5mg/Kg, po, qod<br>* Other names: Pred;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | the time interval between diagnosis and disease progression or death or last follow-up | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | measure with normal serum immunofixation electrophoresis and normal bone marrow feature, and without symptoms and enlarged organs | up to 6 months | 
| overall survival | time interval between diagnosis and death or last follow-up | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mantle cell lymphoma, EDOCH, DHAP, maintenance therapy