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

NCT01746992 — Phase 4, Unknown, 200 participants, Ruijin Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01746992
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	200 (Estimated)
Sponsor	Ruijin Hospital (Other)
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	Cyclophosphamide 750mg/m2, Vincristine 1.4mg/m2, Doxorubicin 50mg/m2, prednisone 60mg/m2, ifosfamide 2000mg/m2, pirarubicin 50mg/m2, pirarubicin 25mg/m2, Etoposide phosphate 100mg/m2, methotrexate 1500mg/m2 (Drug)
Dates	start 2012-09-01, primary completion 2018-09-01 (estimated), completion 2018-12-01 (estimated), first posted 2012-12-11, last updated 2017-11-14
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
pirarubicin	Experimental	Drug: Cyclophosphamide 750mg/m2; Drug: Vincristine 1.4mg/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	3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
doxorubicin	Active comparator	Drug: Cyclophosphamide 750mg/m2; Drug: Vincristine 1.4mg/m2; Drug: Doxorubicin 50mg/m2; Drug: prednisone 60mg/m2	8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)

Cyclophosphamide 750mg/m2 (Drug), also known as CTX: day 1 in both arms
Vincristine 1.4mg/m2 (Drug), also known as VCR: day 1
Doxorubicin 50mg/m2 (Drug), also known as ADM: day 1
prednisone 60mg/m2 (Drug), also known as PRED: day1-day5
ifosfamide 2000mg/m2 (Drug), also known as IFO: day 22-day 24
pirarubicin 50mg/m2 (Drug), also known as THP: day 1
pirarubicin 25mg/m2 (Drug), also known as THP: day 22
Etoposide phosphate 100mg/m2 (Drug), also known as VP-16: day 22-day 24
methotrexate 1500mg/m2 (Drug), also known as MTX: day 43

+Outcome measures

Primary outcomes

complete remission rate [6 months]
3-year PFS [3 years]

Secondary outcomes

overall response rate [6 months]
3-year os [3 years]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Ruijin hospital	Shanghai, Shanghai Municipality	China