CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Primary Purpose
ALK-negative Anaplastic Large Cell Lymphoma, Peripherial T Cell Lymphoma,Not Otherwise Specified, Angioimmunoblastic T Cell Lymphoma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for ALK-negative Anaplastic Large Cell Lymphoma
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
Sites / Locations
- Ruijin hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pirarubicin
doxorubicin
Arm Description
3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
Outcomes
Primary Outcome Measures
complete remission rate
3-year PFS
Secondary Outcome Measures
overall response rate
3-year os
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01746992
Brief Title
CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pirarubicin
Arm Type
Experimental
Arm Description
3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
Arm Title
doxorubicin
Arm Type
Active Comparator
Arm Description
8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide 750mg/m2
Other Intervention Name(s)
CTX
Intervention Description
day 1 in both arms
Intervention Type
Drug
Intervention Name(s)
Vincristine 1.4mg/m2
Other Intervention Name(s)
VCR
Intervention Description
day 1
Intervention Type
Drug
Intervention Name(s)
Doxorubicin 50mg/m2
Other Intervention Name(s)
ADM
Intervention Description
day 1
Intervention Type
Drug
Intervention Name(s)
prednisone 60mg/m2
Other Intervention Name(s)
PRED
Intervention Description
day1-day5
Intervention Type
Drug
Intervention Name(s)
ifosfamide 2000mg/m2
Other Intervention Name(s)
IFO
Intervention Description
day 22-day 24
Intervention Type
Drug
Intervention Name(s)
pirarubicin 50mg/m2
Other Intervention Name(s)
THP
Intervention Description
day 1
Intervention Type
Drug
Intervention Name(s)
pirarubicin 25mg/m2
Other Intervention Name(s)
THP
Intervention Description
day 22
Intervention Type
Drug
Intervention Name(s)
Etoposide phosphate 100mg/m2
Other Intervention Name(s)
VP-16
Intervention Description
day 22-day 24
Intervention Type
Drug
Intervention Name(s)
methotrexate 1500mg/m2
Other Intervention Name(s)
MTX
Intervention Description
day 43
Primary Outcome Measure Information:
Title
complete remission rate
Time Frame
6 months
Title
3-year PFS
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall response rate
Time Frame
6 months
Title
3-year os
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
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