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Trial record 2 of 5 for:    "Subcutaneous panniculitis-like T-cell lymphoma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ruijin Hospital
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01746992
First received: December 4, 2012
Last updated: November 24, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Ruijin Hospital:

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 ]

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 ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746992

Contacts
Contact: WEILI ZHAO 86-21-64370045 ext 665251 zhao.weili@yahoo.com

Locations
China, Shanghai
Ruijin hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: shu CHENG    86-21-64370045 ext 665251    orenge@medmail.com.cn   
Principal Investigator: weili ZHAO         
Sponsors and Collaborators
Ruijin Hospital
  More Information

No publications provided

Responsible Party: Zhao Weili, vice director of Department of Hematology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01746992     History of Changes
Other Study ID Numbers: CTOP
Study First Received: December 4, 2012
Last Updated: November 24, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Enteropathy-Associated T-Cell Lymphoma
Immunoblastic Lymphadenopathy
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell
Panniculitis
Connective Tissue Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Cyclophosphamide
Doxorubicin
Etoposide
Etoposide phosphate
Ifosfamide
Liposomal doxorubicin
Methotrexate
Pirarubicin
Prednisone
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on November 25, 2014