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

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

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

Sponsors & Collaborators

• Ruijin Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2018-09-30

Completion

2018-12-31

Countries

• China

Study Locations