CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma

Conditions
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ALK-negative Anaplastic Large Cell Lymphoma, Peripherial T Cell Lymphoma,Not Otherwise Specified, Angioimmunoblastic T Cell Lymphoma, Enteropathy Associated T Cell Lymphoma, Hepatosplenic T Cell Lymphoma, Subcutaneous Panniculitis Like T Cell Lymphoma

Intervention / Treatment
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* Drug: Cyclophosphamide 750mg/m2
* Drug: Vincristine 1.4mg/m2
* Drug: Doxorubicin 50mg/m2
* Drug: prednisone 60mg/m2
* Drug: ifosfamide 2000mg/m2
* Drug: pirarubicin 50mg/m2
* Drug: pirarubicin 25mg/m2
* Drug: Etoposide phosphate 100mg/m2
* Drug: methotrexate 1500mg/m2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologic verified mature T cell lymphoma,including ALK-negative anaplastic large cell lymphoma,peripherial T cell lymphoma-non specific type,angioimmunoblastic T cell lymphoma,enteropathy associated T cell lymphoma and hepatosplenic T cell lymphoma SGOT/SGPT no more than 2 times of UNL serum creatinine no more than 1.5 times of UNL signed informed consent Exclusion Criteria: woman in pregnancy or lactation allergic to any intervention drug insuitable to the study due to severe complication enrolled to other study during the past 6 months

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pirarubicin<br>3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate | Drug: Cyclophosphamide 750mg/m2<br>* day 1 in both arms<br>* Other names: CTX;Drug: Vincristine 1.4mg/m2<br>* day 1<br>* Other names: VCR;Drug: prednisone 60mg/m2<br>* day1-day5<br>* Other names: PRED;Drug: ifosfamide 2000mg/m2<br>* day 22-day 24<br>* Other names: IFO;Drug: pirarubicin 50mg/m2<br>* day 1<br>* Other names: THP;Drug: pirarubicin 25mg/m2<br>* day 22<br>* Other names: THP;Drug: Etoposide phosphate 100mg/m2<br>* day 22-day 24<br>* Other names: VP-16;Drug: methotrexate 1500mg/m2<br>* day 43<br>* Other names: MTX;|
| Active Comparator: doxorubicin<br>8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone) | Drug: Cyclophosphamide 750mg/m2<br>* day 1 in both arms<br>* Other names: CTX;Drug: Vincristine 1.4mg/m2<br>* day 1<br>* Other names: VCR;Drug: Doxorubicin 50mg/m2<br>* day 1<br>* Other names: ADM;Drug: prednisone 60mg/m2<br>* day1-day5<br>* Other names: PRED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | 6 months | 
| 3-year PFS |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 6 months | 
| 3-year os |  | 3 years |