CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Overview[ - collapse ][ - ]
Purpose | 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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Condition | 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 | 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 |
Phase | Phase 4 |
Sponsor | Ruijin Hospital |
Responsible Party | Ruijin Hospital |
ClinicalTrials.gov Identifier | NCT01746992 |
First Received | December 4, 2012 |
Last Updated | November 24, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 4, 2012 |
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Last Updated Date | November 24, 2013 |
Start Date | September 2012 |
Estimated Primary Completion Date | December 2018 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma |
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Official Title | 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 |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Cyclophosphamide 750mg/m2 day 1 in both arms Other Names: CTXDrug: Vincristine 1.4mg/m2 day 1 Other Names: VCRDrug: Doxorubicin 50mg/m2 day 1 Other Names: ADMDrug: prednisone 60mg/m2 day1-day5 Other Names: PREDDrug: ifosfamide 2000mg/m2 day 22-day 24 Other Names: IFODrug: pirarubicin 50mg/m2 day 1 Other Names: THPDrug: pirarubicin 25mg/m2 day 22 Other Names: THPDrug: Etoposide phosphate 100mg/m2 day 22-day 24 Other Names: VP-16Drug: methotrexate 1500mg/m2 day 43 Other Names: MTX |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 200 |
Estimated Completion Date | December 2018 |
Estimated Primary Completion Date | September 2015 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: WEILI ZHAO 86-21-64370045 zhao.weili@yahoo.com |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01746992 |
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Other Study ID Numbers | CTOP |
Has Data Monitoring Committee | Yes |
Information Provided By | Ruijin Hospital |
Study Sponsor | Ruijin Hospital |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Ruijin hospital | Shanghai, Shanghai, China, 200025 Contact: shu CHENG | 86-21-64370045665251 | orenge@medmail.com.cnPrincipal Investigator: weili ZHAO Recruiting |
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