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.
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 * Enteropathy-associated T-cell lymphoma * Bulky Stage I, Stage II, III or IV * No prior chemotherapy regimen * Patients aged 18 years or over. * WHO performance status 0,1 or 2 * Adequate organ function: * No Central Nervous System(CNS) or leptomeningeal involvement with lymphoma * No treatment for lymphoma within 4 weeks of commencing trial therapy * No known HIV, active Hepatitis B or C infection Treatment: CHOP: cyclophosphamide, doxorubicin, vincristine, prednisolone every 21 days. GEM-P: gemcitabine, methylprednisolone, cisplatin every 28 days. Assessment Schedule: * Patients will be reviewed at baseline and prior to each scheduled dose of treatment for toxicity * Radiological tumour assessment will be done with CT scan after every 2 cycles in Arm A and after cycle 1, 3 and 4 in Arm B * PET/CT scan will be performed at baseline and upon completion of treatment.. * Follow up after completion of treatment will be 3, 6, 9, 12, 18, 24 months then annually for 5 years in total. CT scan will be performed at 3 \& 12 months. * Following disease progression patients will be followed for survival every 3 months until death
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
750mg/m2 IV every 21 days
1000mg/m2 IV Days 1, 8, 15 every 28 days
50mg/m2 IV every 21 days
1.4mg/m2 (max 2mg) IV every 21 days
100mg PO Days 1-5 every 21 days
1000mg oral or IV Days 1-5 every 28 days
100mg/m2 IV Day 15 every 28 days
Royal Marsden NHS Foundation Trust - London and Surrey
London, United Kingdom
complete response rate (CR/CRu)
Time frame: approximately 20 weeks after randomisation
Toxicity
using Common Terminology Criteria for Adverse Events (CTCAE)v4.0
Time frame: approximately 20 weeks after randomisation
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
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