A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liverpool
• Collaborators: Cancer Research UK; Liverpool University Hospitals NHS Foundation Trust; Roche Pharma AG; Royal Liverpool and Broadgreen University Hospitals NHS Trust
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Vincristine

Criteria

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

• 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

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 Modification of Diet in Renal Disease (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 20mg/day continuously or a single course of prednisolone 1 mg/kg for up to 7 days

• Concomitant malignancies except adequately treated localised non-melanoma skin cancer or adequately treated 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