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

Angioimmunoblastic T-cell Lymphoma Clinical Trial

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 Randomised Phase II Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT01719835
• Study type: Interventional
• Source: Royal Marsden NHS Foundation Trust
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2012
• Completion date: August 2022