SCHRIFT

Trial overview

Short CHemoRadioImmunotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab tiuxetan (ZevalinTM) as therapy for first and second relapse in Follicular Lymphoma - a Prospective Phase II study

Inclusion criteria

• Patients must be aged 18 years or older.
• Biopsy-proven follicular NHL, grade 1, 2, or 3a.
• Histologically confirmed CD20+ve follicular NHL.
• First or second relapse after R-Chemo-regimen or chemotherapy alone. Relapse must have occurred at least 6
months after an R-Chemo regimen but may have occurred less than 6 months after chemotherapy alone
• Ann Arbor stage II-IV.
• WHO/ECOG performance status less than or equal to 2.
• Adequate bone marrow, kidney, liver function.
• Normal cardiac ejection fraction required to receive R-CHOP (patients with ejection fraction below normal are eligible for R-CVP) (as defined by echocardiography).
• Written informed consent.

Exclusion criteria

• Primary refractory disease
• Patients who have received investigational drugs <4 weeks prior to entry or who have not recovered from the toxic effects of such therapy
• Previous radioimmunotherapy
• CNS involvement.
• Known HIV infection.
• Other medical illnesses precluding treatment with chemotherapy and/or evaluation.
• > 25% bone marrow involvement with lymphoma, prior to infusion of 90Y ibritumomab tiuxetan (Zevalin). Patients can be entered into the study with > 25% bone marrow involvement at initial restaging, but will require a further bone marrow biopsy before 90Y ibritumomab tiuxetan (Zevalin) administration to confirm that involvement has been reduced to less than 25%.
• Absolute granulocyte count below 1,500/mm3.
• Platelet count below 100,000/mm3.
• Obstructive hydronephrosis
• Pregnancy or breast-feeding.
• Prior malignancy other than lymphoma, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years.