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

NCT01746992 | Unknown Phase 4 DMC

• 1 other identifier: CTOP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• complete remission rate

  6 months

• 3-year PFS

  3 years

Secondary Outcomes (2)

• overall response rate

  6 months

• 3-year os

  3 years

Study Arms (2)

pirarubicin

EXPERIMENTAL

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; 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

doxorubicin

ACTIVE COMPARATOR

8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)

Drug: Cyclophosphamide 750mg/m2; Drug: Vincristine 1.4mg/m2; Drug: Doxorubicin 50mg/m2; Drug: prednisone 60mg/m2

Interventions

Cyclophosphamide 750mg/m2 DRUG

day 1 in both arms

Also known as: CTX

doxorubicin; pirarubicin

Vincristine 1.4mg/m2 DRUG

day 1

Also known as: VCR

doxorubicin; pirarubicin

Doxorubicin 50mg/m2 DRUG

day 1

Also known as: ADM

doxorubicin

prednisone 60mg/m2 DRUG

day1-day5

Also known as: PRED

doxorubicin; pirarubicin

ifosfamide 2000mg/m2 DRUG

day 22-day 24

Also known as: IFO

pirarubicin

pirarubicin 50mg/m2 DRUG

day 1

Also known as: THP

pirarubicin

pirarubicin 25mg/m2 DRUG

day 22

Also known as: THP

pirarubicin

Etoposide phosphate 100mg/m2 DRUG

day 22-day 24

Also known as: VP-16

pirarubicin

methotrexate 1500mg/m2 DRUG

day 43

Also known as: MTX

pirarubicin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy; Enteropathy-Associated T-Cell Lymphoma; Subcutaneous panniculitis-like T-cell lymphoma

Interventions

Cyclophosphamide; Vincristine; Doxorubicin; Prednisone; prednylidene; Ifosfamide; pirarubicin; etoposide phosphate; Etoposide; Methotrexate

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Aminopterin; Pterins; Pteridines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of Department of Hematology

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 11, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CN (1)