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
- Toxicity [ Time Frame: approximately 20 weeks after randomisation ]