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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746992
First Posted: December 11, 2012
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital
  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.


Condition Intervention Phase
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 Drug: 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 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Zhao Weili, Ruijin Hospital:

Primary Outcome Measures:
  • complete remission rate [ Time Frame: 6 months ]
  • 3-year PFS [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • overall response rate [ Time Frame: 6 months ]
  • 3-year os [ Time Frame: 3 years ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CTX
Drug: Vincristine 1.4mg/m2
day 1
Other Name: VCR
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
Active Comparator: doxorubicin
8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746992


Locations
China, Shanghai
Ruijin hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
  More Information

Responsible Party: Zhao Weili, vice director of Department of Hematology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01746992     History of Changes
Other Study ID Numbers: CTOP
First Submitted: December 4, 2012
First Posted: December 11, 2012
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Immunoblastic Lymphadenopathy
Intestinal Diseases
Enteropathy-Associated T-Cell Lymphoma
Panniculitis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy
Gastrointestinal Diseases
Digestive System Diseases
Connective Tissue Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Etoposide phosphate
Pirarubicin
Doxorubicin
Prednisone
Etoposide
Vincristine