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The purpose of this study is to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoposide | Experimental | 50 mg/m2, IV, d1-4 |
|
| Doxorubicin | Experimental | 10 mg/m2, IV, d1-4 |
|
| Dexamethasone | Experimental | 30 mg/d, d1-5 |
|
| Vincristine | Experimental | 0.4 mg/m2, IV, d1-4 |
|
| Cyclophosphamide | Experimental | 750 mg/m2 ,d5 |
|
| Cytarabine | Experimental | 2g/m2, q12h, d1 |
|
| Cisplatin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | 50 mg/m2, IV d1-4 |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuhua Yi, Doc | Blood disease hospital, Chinese Academic Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuhua Yi | Tianjin | 300020 | China |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D004317 | Doxorubicin |
| D003907 | Dexamethasone |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D002945 | Cisplatin |
| D000069283 | Rituximab |
| D013792 | Thalidomide |
| D011241 | Prednisone |
| C036266 | prednylidene |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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100mg/ m2,IV, d1 |
|
| Rituximab | Experimental | 375 mg/m2 IV, d1 |
|
| Thalidomide | Experimental | 50-150mg/d, po, d1-28 |
|
| Prednisone | Experimental | 0.5mg/Kg, po, qod |
|
| Doxorubicin |
| Drug |
10 mg/m2, IV, d1-4 |
|
|
| Dexamethasone | Drug | 30 mg/d, d1-5 |
|
|
| Vincristine | Drug | 0.4 mg/m2, IV, d1-4 |
|
|
| Cyclophosphamide | Drug | 750 mg/m2 ,d5 |
|
|
| Cytarabine | Drug | 2g/m2, q12h, d1 |
|
|
| Cisplatin | Drug | 100mg/ m2,IV, d1 |
|
|
| Rituximab | Drug | 375 mg/m2 IV, d1 |
|
|
| Thalidomide | Drug | 50-150mg/d, po, d1-28 |
|
|
| Prednisone | Drug | 0.5mg/Kg, po, qod |
|
|
| up to 36 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D011244 | Pregnadienediols |