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

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 4

Conditions

ALK-negative Anaplastic Large Cell Lymphoma

Angioimmunoblastic T Cell Lymphoma

Peripherial T Cell Lymphoma,Not Otherwise Specified

Subcutaneous Panniculitis Like T Cell Lymphoma

Enteropathy Associated T Cell Lymphoma

Hepatosplenic T Cell Lymphoma

Treatments

Drug: Doxorubicin 50mg/m2

Drug: Cyclophosphamide 750mg/m2

Drug: Vincristine 1.4mg/m2

Drug: ifosfamide 2000mg/m2

Drug: prednisone 60mg/m2

Drug: pirarubicin 50mg/m2

Drug: pirarubicin 25mg/m2

Drug: methotrexate 1500mg/m2

Drug: Etoposide phosphate 100mg/m2

Study type

Interventional

Funder types

Other

Identifiers

NCT01746992

CTOP

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

pirarubicin

Experimental group

Description:

3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate

Treatment: