CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
NCT ID: NCT01746992
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2012-09-30
2018-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pirarubicin
3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
Cyclophosphamide 750mg/m2
day 1 in both arms
Vincristine 1.4mg/m2
day 1
prednisone 60mg/m2
day1-day5
ifosfamide 2000mg/m2
day 22-day 24
pirarubicin 50mg/m2
day 1
pirarubicin 25mg/m2
day 22
Etoposide phosphate 100mg/m2
day 22-day 24
methotrexate 1500mg/m2
day 43
doxorubicin
8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
Cyclophosphamide 750mg/m2
day 1 in both arms
Vincristine 1.4mg/m2
day 1
Doxorubicin 50mg/m2
day 1
prednisone 60mg/m2
day1-day5
Interventions
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Cyclophosphamide 750mg/m2
day 1 in both arms
Vincristine 1.4mg/m2
day 1
Doxorubicin 50mg/m2
day 1
prednisone 60mg/m2
day1-day5
ifosfamide 2000mg/m2
day 22-day 24
pirarubicin 50mg/m2
day 1
pirarubicin 25mg/m2
day 22
Etoposide phosphate 100mg/m2
day 22-day 24
methotrexate 1500mg/m2
day 43
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SGOT/SGPT no more than 2 times of UNL
* serum creatinine no more than 1.5 times of UNL
* signed informed consent
Exclusion Criteria
* allergic to any intervention drug
* insuitable to the study due to severe complication
* enrolled to other study during the past 6 months
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
vice director of Department of Hematology
Locations
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Ruijin hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CTOP
Identifier Type: -
Identifier Source: org_study_id