Clinical Trial: Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients

Brief Summary: The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell NHL. This is largely due to lower response rates and less durable responses to standard combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the prognosis for PTCL.

Detailed Summary:

Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of lymphoproliferative disorder arising from mature T-cells of post-thymic origin. PTCL represent a relatively uncommon group of hematologic malignancies within non-Hodgkin lymphomas (NHL), accounting for about 10% of NHL cases. The prognosis for PTCL remains poor in comparison to B-cell NHL. This is largely due to lower response rates and less durable responses to standard combination chemotherapy regimens such as CHOP. Progress has been further hampered by the relative rarity and the biological heterogeneity of the diseases. Among PTCL cases worldwide, the most common subtypes include PTCL-not otherwise specified (PTCL-NOS; 26%), angioimmunoblastic T-cell lymphoma (AITL; 18.5%), NK/T-cell lymphoma (10%), adult T-cell leukemia/lymphoma (ATLL; 10%), ALK-positive anaplastic large cell lymphoma (ALCL; 7%) and ALK-negative ALCL (6%); subtypes such as enteropathy-associated T-cell lymphoma (EATL; <5%) and primary cutaneous ALCL are relatively rare (<2%) with ALCL more common than NK/T or ATLL in the United States.

PTCLs are less responsive to and have less frequent durable remissions with standard chemotherapy regimens such as CHOP and thus carry a poorer prognosis compared to diffuse large B-cell lymphomas. In prospective randomized studies, PTCLs have been included with aggressive B-cell lymphomas. However, it has not been possible to assess the impact of chemotherapy in this subgroup of patients with PTCLs due to small sample size. Only limited data exist from randomized trials comparing the efficacy of chemotherapy regimens exclusively in patients with PTCL.

CHOP chemotherapy is the most commonly used first-line regimen for patients with PTCL. However, with the exception of ALK+ ALCL, outcomes are disappointing compared to the favorable results achieved wit
Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: complete remission rate [ Time Frame: 3 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • disease free survival [ Time Frame: 3 years ]
  • overall survival [ Time Frame: 3 years ]
  • time to progression [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: November 3, 2016
Date Started: February 2017
Date Completion: March 2019
Last Updated: January 13, 2017
Last Verified: January 2017