Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT01719835
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 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
Study:
NCT01719835
Study Brief:
Protocol Section:
NCT01719835