Clinical Trial: CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre R

Brief Summary: This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.

Detailed Summary:

Background: T-cell lymphoma is an aggressive rare subset of Non-Hodgkin lymphoma (NHL) comprising several different subtypes of disease within this group. No standard first-line treatment exists for T-cell lymphoma as published series are small, with heterogeneous populations and often retrospective.

PROTOCOL SYNOPSIS Study Period: 5 years

Objectives:

Primary

• To compare the complete response rate of GEM-P with CHOP chemotherapy in the first line treatment of patients with T - cell Lymphoma. Secondary

To investigate, between both arms:

  • Rate of metabolic complete response
  • Toxicity of treatment
  • Overall survival (OS)
  • Progression Free Survival (PFS) Exploratory
  • Investigate impact of International Prognostic Index(IPI) on the outcomes response rate, PFS and OS Study Design: A randomised multi-centre open-label phase II study Indication: Previously untreated T-Cell lymphoma No of Participants: 186 (93 patients in each arm) Main Eligibility Criteria
  • Histologically proven T-cell lymphoma of the following subtypes:
  • Peripheral T-cell lymphoma NOS
  • Systemic Anaplastic large cell lymphoma (ALCL) Anaplastic lymphoma kinase (ALK)negative cases only
  • Angioimmunoblastic T-cell lymphoma
  • Hepatosplenic gamma/ delta T-cell lymphoma
  • Bulky Stage I, Stage II, III or IV<
    Sponsor: Royal Marsden NHS Foundation Trust

    Current Primary Outcome: complete response rate (CR/CRu) [ Time Frame: approximately 20 weeks after randomisation ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Toxicity [ Time Frame: approximately 20 weeks after randomisation ]
      using Common Terminology Criteria for Adverse Events (CTCAE)v4.0
    • Overall Survival [ Time Frame: 1 and 2 years ]
    • Progression Free survival [ Time Frame: 1 and 2 years ]
    • Metabolic Complete Response Rate [ Time Frame: approximately 20 weeks after randomisation ]


    Original Secondary Outcome: Same as current

    Information By: Royal Marsden NHS Foundation Trust

    Dates:
    Date Received: April 12, 2012
    Date Started: March 2012
    Date Completion: August 2022
    Last Updated: October 30, 2012
    Last Verified: October 2012