Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

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.

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.

Eligibility: 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

Relevance to patient case: not relevant