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

Phase 4

• Conditions: 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
• Interventions: 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

• Registration Number: NCT01746992
• Lead Sponsor: Ruijin Hospital

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 available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-09
• Study First Posted: 2012-12-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doxorubicin	Vincristine 1.4mg/m2	8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
pirarubicin	Cyclophosphamide 750mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	Vincristine 1.4mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	Etoposide phosphate 100mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	methotrexate 1500mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
doxorubicin	Cyclophosphamide 750mg/m2	8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
doxorubicin	prednisone 60mg/m2	8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
doxorubicin	Doxorubicin 50mg/m2	8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
pirarubicin	pirarubicin 50mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	prednisone 60mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	ifosfamide 2000mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
pirarubicin	pirarubicin 25mg/m2	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate

Primary Outcome Measures

Name	Time	Method
complete remission rate	6 months
3-year PFS	3 years

Secondary Outcome Measures

Name	Time	Method
overall response rate	6 months
3-year os	3 years

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China