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

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ClinicalTrials.gov Identifier: NCT01746992
Recruitment Status : Active, not recruiting
First Posted : December 11, 2012
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE December 11, 2012
Last Update Posted Date November 14, 2017
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2012)
  • complete remission rate [ Time Frame: 6 months ]
  • 3-year PFS [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01746992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2012)
  • overall response rate [ Time Frame: 6 months ]
  • 3-year os [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: Cyclophosphamide 750mg/m2
    day 1 in both arms
    Other Name: CTX
  • Drug: Vincristine 1.4mg/m2
    day 1
    Other Name: VCR
  • Drug: Doxorubicin 50mg/m2
    day 1
    Other Name: ADM
  • Drug: prednisone 60mg/m2
    day1-day5
    Other Name: PRED
  • Drug: ifosfamide 2000mg/m2
    day 22-day 24
    Other Name: IFO
  • Drug: pirarubicin 50mg/m2
    day 1
    Other Name: THP
  • Drug: pirarubicin 25mg/m2
    day 22
    Other Name: THP
  • Drug: Etoposide phosphate 100mg/m2
    day 22-day 24
    Other Name: VP-16
  • Drug: methotrexate 1500mg/m2
    day 43
    Other Name: MTX
Study Arms  ICMJE
  • Experimental: pirarubicin
    3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
    Interventions:
    • 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
  • Active Comparator: doxorubicin
    8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
    Interventions:
    • Drug: Cyclophosphamide 750mg/m2
    • Drug: Vincristine 1.4mg/m2
    • Drug: Doxorubicin 50mg/m2
    • Drug: prednisone 60mg/m2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01746992
Other Study ID Numbers  ICMJE CTOP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhao Weili, Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ruijin Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP