Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)
Overview
- Phase
- Phase 2
- Intervention
- 90Y Ibritumomab tiuxetan
- Conditions
- Follicular Lymphoma
- Sponsor
- The Christie NHS Foundation Trust
- Enrollment
- 76
- Locations
- 7
- Primary Endpoint
- Overall response rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Emmie Taylor
Lead Clinical Trial Manager
The Christie NHS Foundation Trust
Eligibility Criteria
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
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
Arms & Interventions
Fractionated Initial Zevalin
Intervention: 90Y Ibritumomab tiuxetan
Fractionated Initial Zevalin
Intervention: Rituximab
Outcomes
Primary Outcomes
Overall response rate
Time Frame: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Combined Complete Response rate
Time Frame: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Partial Response Rate
Time Frame: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Secondary Outcomes
- Response duration(Assessed 3 months post treatment, repeated assessment up to 5 years follow-up)
- Time to disease progression(Assessed 3 months post treatment, repeated assessment up to 5 years follow-up)