CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL
1 other identifier
interventional
106
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2015
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 10, 2020
March 1, 2020
3.7 years
July 18, 2015
March 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with complete remission （CR）
6 months
Secondary Outcomes (4)
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
Study Arms (2)
CEOP/IVE/GDP chemotherapy regimen
EXPERIMENTAL2 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
ACTIVE COMPARATOR6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)
Interventions
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: 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200000, China
Related Publications (1)
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.
PMID: 32349779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Wang, PhD
Shanghai Province Hopsital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Hematology Department
Study Record Dates
First Submitted
July 18, 2015
First Posted
August 27, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2019
Study Completion
December 1, 2020
Last Updated
March 10, 2020
Record last verified: 2020-03