CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02533700|
Recruitment Status : Unknown
Verified March 2020 by Wang Xin, Shandong Provincial Hospital.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2015
Last Update Posted : March 10, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: CEOP/IVE/GDP chemotherapy regimen Drug: CEOP chemotherapy regimen for 6 cycles||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: 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)
Drug: CEOP/IVE/GDP chemotherapy regimen
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
Ifosfamide 2000mg/m2,ivgtt D1-D3 Epirubucin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3
Gemcitabine 1g/m2,ivgtt D1,D8 Cis-platinum 25mg/m2, ivgtt D1-D3 Dexamethasone 40mg, ivgtt D1-D4
Active Comparator: CEOP chemotherapy regimen for 6 cycles
6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)
Drug: CEOP chemotherapy regimen for 6 cycles
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
- Percentage of patients with complete remission （CR） [ Time Frame: 6 months ]
- progression-free survival [ Time Frame: 2 year since randomization ]
- overall survival [ Time Frame: 2 year since randomization ]
- overall response rate [ Time Frame: 6 months ]
- adverse events [ Time Frame: from randomization to one month after last cycle of treatment ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533700
|Fujian Medical University Union Hospital|
|Fuzhou, Fujian, China|
|Henan Cancer Hospital|
|Zhengzhou, Henan, China|
|Shandong Provincial Hospital|
|Jinan, Shandong, China, 250021|
|Shanghai Ruijin Hospital|
|Shanghai, Shanghai, China, 200000|
|Principal Investigator:||Xin Wang, PhD||Shanghai Province Hopsital|
|Responsible Party:||Wang Xin, Director of Hematology Department, Shandong Provincial Hospital|
|Other Study ID Numbers:||
|First Posted:||August 27, 2015 Key Record Dates|
|Last Update Posted:||March 10, 2020|
|Last Verified:||March 2020|
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Enteropathy-Associated T-Cell Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Connective Tissue Diseases