Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01493479
• Date of registration: 14/12/2011
• Prospective Registration: No
• Primary sponsor: The Christie NHS Foundation Trust
• Public title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma FIZZ
• Scientific title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)
• Date of first enrolment: June 6, 2007
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01493479
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France, United Kingdom

Contacts

• Name: Timothy Illidge, Prof
• Affiliation: The Christie NHS Foundation Trust

Key inclusion & exclusion 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

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Follicular Lymphoma

Intervention(s)

Drug: 90Y Ibritumomab tiuxetan

Drug: Rituximab

Primary Outcome(s)

Combined Complete Response rate [Time Frame: Assessed 3 months post treatment]

Overall response rate [Time Frame: Assessed 3 months post treatment]

Partial Response Rate [Time Frame: Assessed 3 months post treatment]

Secondary Outcome(s)

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]

Secondary ID(s)

06_DOG05_33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer