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T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and predisone)is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma.
Between 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the Northern Region of England and Scotland,which is a rare and aggressive type of peripheral T-cell lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine, etoposide/methotrexate)-ASCT was piloted for patients eligible for intensive treatment,followed by auto-stem cell transplantation.Five-years PFS and OS were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripherial T cell lymphoma-non specified(PTCL-nos).
Past studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin in vitro based on its high concentration in tumor cells. Clinical data also presented equivalent even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The aim of our study is to compare the response and survival rate of CTOP/ITE/MTX (cyclophosphamide, vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin, etoposide/methotrexate) with those of CHOP regimen,looking forward to its superiority in efficacy and safety for the de novo young patients with T cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pirarubicin | Experimental | 3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate |
|
| doxorubicin | Active Comparator | 8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide 750mg/m2 | Drug | day 1 in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | 6 months | |
| 3-year PFS | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | 6 months | |
| 3-year os | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital | Shanghai | Shanghai Municipality | 200025 | China |
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| Vincristine 1.4mg/m2 | Drug | day 1 |
|
|
| Doxorubicin 50mg/m2 | Drug | day 1 |
|
|
| prednisone 60mg/m2 | Drug | day1-day5 |
|
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| ifosfamide 2000mg/m2 | Drug | day 22-day 24 |
|
|
| pirarubicin 50mg/m2 | Drug | day 1 |
|
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| pirarubicin 25mg/m2 | Drug | day 22 |
|
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| Etoposide phosphate 100mg/m2 | Drug | day 22-day 24 |
|
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| methotrexate 1500mg/m2 | Drug | day 43 |
|
|
| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| D058527 | Enteropathy-Associated T-Cell Lymphoma |
| C537503 | Subcutaneous panniculitis-like T-cell lymphoma |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| C036266 | prednylidene |
| D007069 | Ifosfamide |
| C027260 | pirarubicin |
| C061400 | etoposide phosphate |
| D005047 | Etoposide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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