CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL
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|ClinicalTrials.gov Identifier: NCT02533700|
Recruitment Status : Unknown
Verified April 2016 by Wang Xin, Shandong Provincial Hospital.
Recruitment status was: Recruiting
First Posted : August 27, 2015
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-Cell Lymphoma Angioimmunoblastic T Cell Lymphoma ALK-negative Anaplastic Large Cell Lymphoma Enteropathy Associated T Cell Lymphoma Subcutaneous Panniculitis Like T Cell Lymphoma Acute Adult T-Cell Leukemia/Lymphoma||Drug: CEOP/IVE/GDP chemotherapy regimen Drug: CEOP chemotherapy regimen for 6 cycles||Phase 4|
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, vincristine, etoposide/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, about 30% patients with PTCL have no 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, pharmorubicin and prednisone/ ifosfamide, pharmorubicin, 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)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: CEOP/IVE/GDP chemotherapy regimen
2 cycles of CEOP(cyclophosphamide,vincristine, pharmorubicin and prednisone),2 cycles of IVE(ifosfamide, pharmorubicin, etoposide phosphate)and 2 cycles of GDP(gemcitabine, cis-platinum, and dexamethasone)
Drug: CEOP/IVE/GDP chemotherapy regimen
Cyclophosphamide 750mg/m2, ivgtt D1 Pharmorubicin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2,PO,D1-D5
Fosfamide 2000mg/m2,ivgtt D1-D3 Pharmorubicin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3
Active Comparator: CEOP chemotherapy regimen for 6 cycles
6 cycles of CEOP regimen(cyclophosphamide,vincristin,pharmorubicin and prednisone)
Drug: CEOP chemotherapy regimen for 6 cycles
Cyclophosphamide 750mg/m2, ivgtt D1 Pharmorubicin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2,PO,D1-D5 every 21 days for total 6 courses
- Percentage of patients with complete remission （CR） [ Time Frame: 6 months ]Sum of products of greatest diameters （SPD）was used to evaluate the therapy effect.Number of participants with CR was assessed by Chelon Standard.
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
|Shandong Provincial Hospital||Recruiting|
|Jinan, Shandong, China, 250021|
|Contact: Xin Wang, MD, PHD 86-531-13156012606 email@example.com|
|Contact: Yujie Jiang, MD 86-531-13370506886 firstname.lastname@example.org|