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

November 10, 2017 updated by: Zhao Weili, Ruijin Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pirarubicin
3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
Drug: Cyclophosphamide 750mg/m2
day 1 in both arms
Other Names:
  • CTX
Drug: Vincristine 1.4mg/m2
day 1
Other Names:
  • VCR
Drug: prednisone 60mg/m2
day1-day5
Other Names:
  • PRED
Drug: ifosfamide 2000mg/m2
day 22-day 24
Other Names:
  • IFO
Drug: pirarubicin 50mg/m2
day 1
Other Names:
  • THP
Drug: pirarubicin 25mg/m2
day 22
Other Names:
  • THP
Drug: Etoposide phosphate 100mg/m2
day 22-day 24
Other Names:
  • VP-16
Drug: methotrexate 1500mg/m2
day 43
Other Names:
  • MTX
Active Comparator: doxorubicin
8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
Drug: Cyclophosphamide 750mg/m2
day 1 in both arms
Other Names:
  • CTX
Drug: Vincristine 1.4mg/m2
day 1
Other Names:
  • VCR
Drug: prednisone 60mg/m2
day1-day5
Other Names:
  • PRED
Drug: Doxorubicin 50mg/m2
day 1
Other Names:
  • ADM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission rate
Time Frame: 6 months
6 months
3-year PFS
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: 6 months
6 months
3-year os
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 9, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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