NCT01719835

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

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 Randomised Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Peripheral T-cell Lymphoma NOS
• Anaplastic Large Cell Lymphoma, ALK-Negative
• Angioimmunoblastic T-cell Lymphoma
• Hepatosplenic Gamma/ Delta T-cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	750mg/m2 IV every 21 days
DRUG	Gemcitabine	1000mg/m2 IV Days 1, 8, 15 every 28 days
DRUG	Doxorubicin	50mg/m2 IV every 21 days
DRUG	Vincristine	1.4mg/m2 (max 2mg) IV every 21 days
DRUG	Prednisolone	100mg PO Days 1-5 every 21 days
DRUG	methylprednisolone	1000mg oral or IV Days 1-5 every 28 days
DRUG	Cisplatin	100mg/m2 IV Day 15 every 28 days

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-11-30
• Completion: 2022-08-01
• First posted: 2012-11-01
• Last updated: 2018-03-15

Locations

1 site across 1 country: United Kingdom