Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02533700
Other study ID # WXin
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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, etoposideļ¼Œepirubucin/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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02561273 - Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Completed NCT02168140 - CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma Phase 1
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Terminated NCT01678443 - Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Phase 1
Completed NCT01466881 - Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma Phase 2
Terminated NCT01408043 - Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma N/A
Completed NCT00731536 - Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands Phase 4
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00131937 - Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma Phase 2
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Withdrawn NCT04639843 - Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma Phase 1
Completed NCT01254578 - Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers Phase 1
Completed NCT01748721 - MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Completed NCT00901147 - Study of Bortezomib and Panobinostat in Treating Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or NK/T-cell Lymphoma Phase 2
Terminated NCT00101205 - Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Completed NCT00040846 - Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies Phase 2
Completed NCT00112593 - Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer N/A
Completed NCT01129193 - AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma Phase 1