This trial is looking at a combination of rituximab and chemotherapy as a treatment for follicular lymphoma in patients 60 years of age and older.

• Conditions: Follicular Lymphoma in patients aged 60 or over or less than 60 but considered unfit for more aggressive treatment.; MedDRA version: 14.0Level: LLTClassification code 10025311Term: Lymphoma (non-Hodgkin's)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-004759-31-GB
• Lead Sponsor: niversity of Liverpool (lead sponsor, the trial is co-sponsored)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Main Criteria for Inclusion: • Histologically confirmed follicular lymphoma (grade 1,2, and 3a with material available for central review) • Ann Arbor stage II-IV • Aged 60 years or over, or aged less than 60 but anthracycline-based therapy contra- indicated • No prior systemic therapy (one episode of prior local radiotherapy is allowed) • At least one of the following criteria for initiation of treatment: • Rapid generalized disease progression in the preceding 3 months • Life threatening organ involvement • Renal or macroscopic liver infiltration • Bone lesions • Presence of systemic symptoms or pruritus • Haemoglobin < 10 g/dL or WBC < 3.0 × 109/L or platelet counts < 100 × 109/L due to marrow involvement • Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow): • Haemoglobin = 8.0 g/dL • Absolute neutrophil count (ANC) = 1.5 x 109/L • Platelet count = 100 x 109/L • Written Informed Consent
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Overt transformation to diffuse large B-cell lymphoma • Grade 3b follicular lymphoma • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis) • WHO performance status 3 or 4 • Impaired renal function defined as estimated Glomerular filtration rate (eGFR) < 30 mL/min using the MDRD formula • Impaired hepatic function defined as serum bilirubin more than twice upper limit of normal (unless due to lymphoma or Gilbert's syndrome) • Life expectancy less than 12 months • Pre-existing neuropathy • Active auto-immune haemolytic anaemia • Serological evidence of infection with HIV, hepatitis B(positivity for surface antigen or core antibody)or hepatitis C • Allergy to murine proteins • Corticosteroid treatment during the last 4 weeks, unless administered at a dose equivalent to no more than prednisolone 20 mg/day continuously or a single course of prednisolone 1mg/kg for up to 7 days • Concomitant malignancies except adequately treated localised non-melanoma skin cancer or in situ cervical cancer, or cancers that have been in remission for at least 5 years following surgery with curative intent • Major surgery (excluding lymph node biopsy) within 28 days prior to randomisation • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) • Treatment within a clinical trial within 30 days prior to trial entry • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent • Adult patient under tutelage (not competent to sign informed consent) • Pregnant or lactating women • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom

Study & Design

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