Clinical trial NCT02533700: CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL
Official title: CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-Cell Lymphoma, Not Otherwise Specified
Angioimmunoblastic T Cell Lymphoma
ALK-negative Anaplastic Large Cell Lymphoma
Enteropathy Associated T Cell Lymphoma
Subcutaneous Panniculitis Like T Cell Lymphoma
Hepatosplenic T-cell Lymphoma
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2015-08-27
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) 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. So, clinical trials are encouraged by NCCN for those patients.

Detailed description: For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been the therapy tendency in PTCL. The novel regimen IVE/MTX (ifosfamide, etoposide，epirubucin/methotrexate)-ASCT(autologous stem-cell transplantation ) was piloted for patients eligible for intensive treatment, followed by auto-stem cell transplantation. Five-years PFS (progression-free survival) and OS (overall survival) were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripheral T cell lymphoma-non specified (PTCL-NOS). Former studies reported that GDP (gemcitabine, cis-platinum, and dexamethasone) compared with CHOP as the therapy strategy for PTCL-NOS (not otherwise specified). The response rate was 78.57% in GDP group and 60.00% in CHOP group respectively. DFS (disease-free survival) was 9.79 and 4.2 months in above two groups. They concluded that GDP is superior with CHOP. The main side-effect of two regimens is hematological toxicity. Furthermore, high-dose combined with ASCT has been the first-line therapy for PTCL. However, only about 30% patients with PTCL have chance to receive ASCT for multiple reasons. So it is urgent to explore new combination-therapy regimen to improve the outcome for patients with PTCL.

The aim of our study is to compare the response and survival rate of CEOP/IVE/GDP (cyclophosphamide, vincristin, epirubucin and prednisone/ ifosfamide, epirubucin, and etoposide/ gemcitabine, cis-platinum, and dexamethasone) with those of CEOP regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, histologically confirmed the following pathology subtype according to WHO 2008 classification: peripheral T Cell Lymphoma, not otherwise specified, angioimmunoblastic T cell lymphoma, ALK-negative anaplastic large cell lymphoma, enteropathy associated T cell lymphoma, subcutaneous panniculitis like T cell lymphoma, and hepatosplenic T-cell lymphoma.
* ≥ 16 years of age.
* Performance status of 2 or less.
* Has no history of malignancy.
* Has radiologically measurable disease.
* Life expectancy ≥6 months.
* Voluntarily sign an informed consent.

Exclusion Criteria:

* Pathology subtype with NK/T cell lymphoma, ALK positive-ALCL.
* Primary central nervous system (CNS) lymphoma.
* Previous systemic chemotherapy or local therapy.
* Has undergone hematopoietic stem-cell transplantation (HSCT).
* Has active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy.
* Has uncontrollable cardiocerebrovascular, coagulative, autoimmune, or serious infectious disease.
* Echocardiography shows left ventricular ejection fraction (LVEF) ≤ 50%.
* Inadequate renal, hepatic or bone marrow function
* Active liver or biliary disease.
* Has other uncontrollable medical condition that may interfere with their participation in the study.
* Woman in pregnancy or lactation.
* Patient is known to be positive for Human immunodeficiency virus (HIV) infection.

Primary outcomes:
measure: Percentage of patients with complete remission （CR）
timeFrame: 6 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 2 year since randomization
measure: overall survival
timeFrame: 2 year since randomization
measure: overall response rate
timeFrame: 6 months
measure: adverse events
timeFrame: from randomization to one month after last cycle of treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Province Hopsital
name: Xin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cai MC, Cheng S, Wang X, Hu JD, Song YP, Huang YH, Yan ZX, Jiang YJ, Fang XS, Zheng XY, Dong LH, Ji MM, Wang L, Xu PP, Zhao WL. CEOP/IVE/GDP alternating regimen compared with CEOP as the first-line therapy for newly diagnosed patients with peripheral T cell lymphoma: results from a phase 2, multicenter, randomized, controlled clinical trial. Genome Med. 2020 Apr 30;12(1):41. doi: 10.1186/s13073-020-00739-0.