NCT01746992

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Cyclophosphamide 750mg/m2	day 1 in both arms
DRUG	Vincristine 1.4mg/m2	day 1
DRUG	Doxorubicin 50mg/m2	day 1
DRUG	prednisone 60mg/m2	day1-day5
DRUG	ifosfamide 2000mg/m2	day 22-day 24
DRUG	pirarubicin 50mg/m2	day 1
DRUG	pirarubicin 25mg/m2	day 22
DRUG	Etoposide phosphate 100mg/m2	day 22-day 24
DRUG	methotrexate 1500mg/m2	day 43

Timeline

• Start date: 2012-09-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2012-12-11
• Last updated: 2017-11-14

Locations

1 site across 1 country: China