Trial Overview

Phase 3

Older patients

Follicular Lymphoma

Comparison of 1st line R-CVP V R-FC

Inclusion criteria

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

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 × 10

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 10

Platelet count ≥ 100 x 10

Written Informed Consent

9/L or platelet counts < 100 × 109/L due to marrow involvement 9/L 9/L

Exclusion criteria

Prior anti-lymphoma treatment

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

Creatinine clearance < 30 mL/min

Serum bilirubin more than twice upper limit of normal (unless due to lymphoma)

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

Regular corticosteroid treatment during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisolone

Concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer

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

Research Nurse

Amy Codrington

Tel: 0113 2068984

E-mail: [email protected]

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