This trial is active, not recruiting.

Condition follicular lymphoma
Treatments 90y ibritumomab tiuxetan, rituximab
Phase phase 2
Target CD20
Sponsor Christie Hospital NHS Foundation Trust
Collaborator Bayer
Start date June 2007
End date September 2015
Trial size 76 participants
Trial identifier NCT01493479, 06_DOG05_33


90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
90y ibritumomab tiuxetan Zevalin
2 x iv infusions of 11.1 MBq/kg. 1st infusion at week 1, 2nd during weeks 9-13. 2nd infusion may be reduced to 7.4MBq/kg in the case of grade 3 haematological toxicity following the 1st infusion.
rituximab Mabthera
All patients receive 2 x iv infusions of 250 mg/m2 Rituximab given 7-8 days apart prior to each zevalin infusion. The 2nd rituximab infusion is given immediately prior to Zevalin. In addition patients with greater than 20% bone marrow involvement at screening receive rituximab pretreatment prior to entering the main treatment phase of the trial, consisting of 4 x weekly iv doses of rituximab(375 mg/m2). This is followed by a repeat bone marrow biopsy, bone marrow involvement must have fallen to <= 20% to enter the main treatment phase of the trial.

Primary Outcomes

Overall response rate
time frame: Assessed 3 months post treatment
Combined Complete Response rate
time frame: Assessed 3 months post treatment
Partial Response Rate
time frame: Assessed 3 months post treatment

Secondary Outcomes

Time to disease progression
time frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up
Response duration
time frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have a histologically confirmed CD20 +ve follicular lymphoma grades I to IIIa. - Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below) - Nodal mass > 7cm in its greater diameter - B symptoms - Elevated serum LDH or beta2-microglobulin - involvement of at least 3 nodal sites (each with a diameter > 3 cm) - symptomatic splenic enlargement - compressive syndrome - Patients must have an ECOG performance status less than or equal to 2 and an anticipated survival of at least 6 months. - Patients must have an absolute granulocyte count of above 1,500/mm3, and a platelet count of above 100,000/mm3 post 4 weeks of unlabelled Rituximab. A hemoglobin >= 8.0 g/dl - Patients must have adequate renal function (defined as calculated creatinine clearance > 30 ml/mn), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal) - Patients must have given informed consent prior to study entry. Exclusion Criteria: - Patients with a mean of >20% of the intratrabecular marrow space involved with lymphoma on bone marrow biopsy following induction Rituximab therapy. - Transformed follicular lymphoma and discordant lymphoma - Patients with active obstructive hydronephrosis. - Patients with initial disease bulk greater than 10cm. - Patients with evidence of active infection requiring i.v. antibiotics at the time of study entry. - Patients with congestive heart failure stage III or IV of NYHA classification, myocardial infraction or unstable angina within 6 months or other serious illness that would preclude evaluation. - Patients with left VEF < 40% - Patients with large pleural or peritoneal effusions. - Patients with known HIV infection or active HBV (HbsAg positivity) or HCV infection. - Known Hypersensitivity to murine antibodies or proteins - Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following 90Y-ibritumomab tiuxetan antibody therapy. - Patients with 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.

Additional Information

Official title Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)
Principal investigator Timothy Illidge, Prof
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Christie Hospital NHS Foundation Trust.