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
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
- 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, Hepatitis C or active Hepatitis B viral 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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
complete response rate (CR/CRu)
approximately 20 weeks after randomisation
No
David Cunningham, MD FRCP
Principal Investigator
Royal Marsden NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency
RMH CCR: 3549
NCT01719835
March 2012
August 2022
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