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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by The Christie NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
Information provided by:
The Christie NHS Foundation Trust Identifier:
First received: December 14, 2011
Last updated: December 15, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Follicular Lymphoma Drug: 90Y Ibritumomab tiuxetan Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)

Resource links provided by NLM:

Further study details as provided by The Christie NHS Foundation Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
    To be assessed for patients achieving a response, including assessment of overall survival and time until next treatment.

Enrollment: 76
Study Start Date: June 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fractionated Initial Zevalin Drug: 90Y Ibritumomab tiuxetan
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.
Other Name: Zevalin
Drug: Rituximab

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.

Other Name: Mabthera


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01493479

Centre Hospitalier Universitaire de Lille
Lille, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Henri Becquerel
Rouen, France
United Kingdom
St George's Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Poole Hospital NHS Foundation Trust
Poole, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Sponsors and Collaborators
The Christie NHS Foundation Trust
Principal Investigator: Timothy Illidge, Prof The Christie NHS Foundation Trust
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01493479     History of Changes
Other Study ID Numbers: 06_DOG05_33
Study First Received: December 14, 2011
Last Updated: December 15, 2011

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017