ALK-negative Anaplastic Large Cell Lymphoma Clinical Trial
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
| Verified date | November 2017 |
| Source | Ruijin Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | December 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Ruijin hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complete remission rate | 6 months | ||
| Primary | 3-year PFS | 3 years | ||
| Secondary | overall response rate | 6 months | ||
| Secondary | 3-year os | 3 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02533700 -
CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL
|
Phase 2 | |
| Completed |
NCT01198665 -
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
|
Phase 1/Phase 2 |