Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01719835
Status:
UNKNOWN
Last Update Posted:
2018-03-15
First Post:
2012-04-12
Brief Title:
CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma Multicentre Phase II Study
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
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 Lymphomaa Multicentre Randomised Phase II Study
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHEMO-T
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 11 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 01 or 2
Adequate organ function
No Central Nervous SystemCNS 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
PETCT 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
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 01 or 2
Adequate organ function
No Central Nervous SystemCNS 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
PETCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-004146-18 | EUDRACT_NUMBER | None | None |