ALK-negative Anaplastic Large Cell Lymphoma, Angioimmunoblastic T Cell Lymphoma, Enteropathy Associated T Cell Lymphoma, Hepatosplenic T Cell Lymphoma, Peripherial T Cell Lymphoma,Not Otherwise Specified, Subcutaneous Panniculitis Like T Cell Lymphoma
Conditions
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.
Interventions
DRUGCyclophosphamide 750mg/m2
day 1 in both arms
DRUGVincristine 1.4mg/m2
day 1
DRUGDoxorubicin 50mg/m2
day 1
DRUGprednisone 60mg/m2
day1-day5
DRUGifosfamide 2000mg/m2
day 22-day 24
DRUGpirarubicin 50mg/m2
day 1
DRUGpirarubicin 25mg/m2
day 22
DRUGEtoposide phosphate 100mg/m2
day 22-day 24
DRUGmethotrexate 1500mg/m2
day 43
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate | 6 months |
| 3-year PFS | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 3-year os | 3 years |
| overall response rate | 6 months |
Countries
China
Outcome results
None listed