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

• Conditions: T-cell Lymphoma; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 14.0Level: HLTClassification code 10001414Term: Adult T-cell lymphomas/leukaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2011-004146-18-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Previously untreated, histologically proven T-cell Lymphoma (any of the following): - Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS) - Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only - Angioimmunoblastic T-cell lymphoma - Hepatosplenic gamma/ delta T-cell lymphoma 2. Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV. 3. Age =18 years on the day of signing informed consent. 4. WHO performance status 0, 1 or 2. 5. Baseline 18FDG-PET scans must demonstrate FDG avid disease compatible with CT defined anatomical tumour sites. 6. Adequate bone marrow, cardiac, renal, hepatic and respiratory function.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1. Documented or symptomatic central nervous system involvement or leptomeningeal disease. 2. Patients with negative FDG-PET/CT scan at baseline 3. Any other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial. 4. Prior malignancy within the last 5 years 5. Treatment with another investigational agent within 30 days of commencing study treatment. 6. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or active hepatitis B infection. 7. Patients with poorly controlled diabetes mellitus

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified