CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

Phase 2

• Conditions: ALK-negative Anaplastic Large Cell Lymphoma; Peripheral T-Cell Lymphoma, Not Otherwise Specified; Enteropathy Associated T Cell Lymphoma; Hepatosplenic T-cell Lymphoma; Angioimmunoblastic T Cell Lymphoma; Subcutaneous Panniculitis Like T Cell Lymphoma
• Interventions: Drug: CEOP/IVE/GDP chemotherapy regimen; Drug: CEOP chemotherapy regimen for 6 cycles

• Registration Number: NCT02533700
• Lead Sponsor: Shandong Provincial Hospital

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.

Study Timeline

• Study First Submitted: 2015-07-18
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2015-09
• Primary Completion: 2019-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEOP/IVE/GDP chemotherapy regimen	CEOP/IVE/GDP chemotherapy regimen	2 cycles of CEOP(cyclophosphamide,vincristine, epirubucin and prednisone),2 cycles of IVE(ifosfamide, epirubucin, etoposide)and 2 cycles of GDP(gemcitabine, cis-platinum, and dexamethasone)
CEOP chemotherapy regimen for 6 cycles	CEOP chemotherapy regimen for 6 cycles	6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete remission （CR）	6 months

Secondary Outcome Measures

Name	Time	Method
progression-free survival	2 year since randomization
overall survival	2 year since randomization
overall response rate	6 months
adverse events	from randomization to one month after last cycle of treatment

Trial Locations

Locations (4)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China