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

Hepatosplenic T-cell Lymphoma Clinical Trial

Official title:

CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02533700
• Other study ID #: WXin
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: December 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALK-negative Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T Cell Lymphoma
• Enteropathy Associated T Cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Hepatosplenic T-cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Panniculitis
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Subcutaneous Panniculitis Like T Cell Lymphoma

Intervention

Drug:
• CEOP/IVE/GDP chemotherapy regimen
CEOP: Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2(max 2mg), ivgtt D1 Prednisone 60mg/m2 (max 100mg),PO,D1-D5 IVE: Ifosfamide 2000mg/m2,ivgtt D1-D3 Epirubucin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3 GDP: Gemcitabine 1g/m2,ivgtt D1,D8 Cis-platinum 25mg/m2, ivgtt D1-D3 Dexamethasone 40mg, ivgtt D1-D4
• CEOP chemotherapy regimen for 6 cycles
CEOP: Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2(max 2mg), ivgtt D1 Prednisone 60mg/m2 (max 100mg),PO,D1-D5 every 21 days for total 6 courses

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete remission (CR)		6 months
Secondary	progression-free survival		2 year since randomization
Secondary	overall survival		2 year since randomization
Secondary	overall response rate		6 months
Secondary	adverse events		from randomization to one month after last cycle of treatment