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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
Sponsor:
Information provided by (Responsible Party):
Wang Xin, 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.

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

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, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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

CEOP:

Cyclophosphamide 750mg/m2, ivgtt D1 Pharmorubicin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2(max 2mg), ivgtt D1 Prednisone 60mg/m2,PO,D1-D5

IVE:

Fosfamide 2000mg/m2,ivgtt D1-D3 Pharmorubicin 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

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

CEOP:

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





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 acute T-cell leukemia/lymphoma
  • SGOT(serum glutamate oxaloacetate transaminase)/SGPT(serum glutamate pyruvate transaminase ) no more than 2 times of UNL (upper normal limit )
  • serum creatinine no more than 1.5 times of UNL
  • signed informed consent

Exclusion Criteria:

  • woman in pregnancy or lactation
  • allergic to any intervention drug
  • unsuitable to the study due to severe complication
  • enrolled to other study during the past 6 months
  • NK(natural killer)/T lymphoma
  • ALK-positive Anaplastic Large Cell Lymphoma

Information from the National Library of Medicine

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


Locations
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China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Xin Wang, MD, PHD    86-531-13156012606    xinw@sdu.edu.cn   
Contact: Yujie Jiang, MD    86-531-13370506886    yujiejiang05@126.com   
Sponsors and Collaborators
Shandong Provincial Hospital

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Responsible Party: Wang Xin, Director of Hematology Department, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT02533700     History of Changes
Other Study ID Numbers: WXin
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Intestinal Diseases
Enteropathy-Associated T-Cell Lymphoma
Panniculitis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia
Lymphadenopathy
Gastrointestinal Diseases
Digestive System Diseases
Connective Tissue Diseases
Skin Diseases
Cyclophosphamide
Prednisone
Vincristine
Epirubicin
Immunosuppressive Agents
Immunologic Factors