Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT01719835
Status:
UNKNOWN
Last Update Posted:
2018-03-15
First Post:
2012-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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 Lymphoma,a 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 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
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 Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-004146-18 | EUDRACT_NUMBER | None | View |