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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionALK-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
InterventionDrug: Cyclophosphamide 750mg/m2
Drug: Vincristine 1.4mg/m2
Drug: Doxorubicin 50mg/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
PhasePhase 4
SponsorRuijin Hospital
Responsible PartyRuijin Hospital
ClinicalTrials.gov IdentifierNCT01746992
First ReceivedDecember 4, 2012
Last UpdatedNovember 24, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateDecember 4, 2012
Last Updated DateNovember 24, 2013
Start DateSeptember 2012
Estimated Primary Completion DateDecember 2018
Current Primary Outcome Measures
  • complete remission rate [Time Frame: 6 months] [Designated as safety issue: Yes]
  • 3-year PFS [Time Frame: 3 years] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • overall response rate [Time Frame: 6 months] [Designated as safety issue: Yes]
  • 3-year os [Time Frame: 3 years] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleCTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Official TitleAn 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • 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
InterventionDrug: Cyclophosphamide 750mg/m2
day 1 in both arms
Other Names:
CTXDrug: Vincristine 1.4mg/m2
day 1
Other Names:
VCRDrug: Doxorubicin 50mg/m2
day 1
Other Names:
ADMDrug: prednisone 60mg/m2
day1-day5
Other Names:
PREDDrug: ifosfamide 2000mg/m2
day 22-day 24
Other Names:
IFODrug: pirarubicin 50mg/m2
day 1
Other Names:
THPDrug: pirarubicin 25mg/m2
day 22
Other Names:
THPDrug: Etoposide phosphate 100mg/m2
day 22-day 24
Other Names:
VP-16Drug: methotrexate 1500mg/m2
day 43
Other Names:
MTX
Study Arm (s)
  • Experimental: pirarubicin
    3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
  • Active Comparator: doxorubicin
    8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment200
Estimated Completion DateDecember 2018
Estimated Primary Completion DateSeptember 2015
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: WEILI ZHAO
86-21-64370045
zhao.weili@yahoo.com
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01746992
Other Study ID NumbersCTOP
Has Data Monitoring CommitteeYes
Information Provided ByRuijin Hospital
Study SponsorRuijin Hospital
CollaboratorsNot Provided
Investigators Not Provided
Verification DateNovember 2013

Locations[ + expand ][ + ]

Ruijin hospital
Shanghai, Shanghai, China, 200025
Contact: shu CHENG | 86-21-64370045665251 | orenge@medmail.com.cn
Principal Investigator: weili ZHAO
Recruiting