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Follicular LymphomaPhase 2FIZZNCT01493479

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

A Phase 2 study testing 90Y Ibritumomab tiuxetan and Rituximab in people with Follicular Lymphoma, run by The Christie NHS Foundation Trust at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
90Y Ibritumomab tiuxetan and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
7 sitesin 2 countries
Study dates
6 Jun 2007to 6 Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United Kingdom4 sites

  • St George's Hospital

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Poole Hospital NHS Foundation Trust

    Poole

  • Southampton University Hospital

    Southampton

Other trials in United Kingdom

France3 sites

  • Centre Hospitalier Universitaire de Lille

    Lille

  • Centre Hospitalier Universitaire de Nantes

    Nantes

  • Centre Henri Becquerel

    Rouen

Other trials in France

About this study

Official title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)

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.

Being tested
90Y Ibritumomab tiuxetan, Rituximab
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 90Y Ibritumomab tiuxetanDrug

    Also called 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.

  • RituximabDrug

    Also called 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.

Study groups in NCT01493479
Study groupRoleWhat they receive
Fractionated Initial ZevalinExperimentalNot described
Receives: Drug: 90Y Ibritumomab tiuxetan; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.

    Measured: Assessed 3 months post treatment

  2. Combined Complete Response rate

    According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.

    Measured: Assessed 3 months post treatment

  3. Partial Response Rate

    According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.

    Measured: Assessed 3 months post treatment

Secondary outcomes (2)

  1. Time to disease progression

    Measured: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up

  2. Response duration

    To be assessed for patients achieving a response, including assessment of overall survival and time until next treatment.

    Measured: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study start6 Jun 2007
  3. Primary completionJan 2011
  4. Study completion6 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493479
Sponsor's protocol ID
06_DOG05_33
Acronym
FIZZ
Status last verified
Oct 2019
First submitted
14 Dec 2011
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Illidge TM, Mayes S, Pettengell R, Bates AT, Bayne M, Radford JA, Ryder WD, Le Gouill S, Jardin F, Tipping J, Zivanovic M, Kraeber-Bodere F, Bardies M, Bodet-Milin C, Malek E, Huglo D, Morschhauser F. Fractionated (9)(0)Y-ibritumomab tiuxetan radioimmunotherapy as an initial therapy of follicular lymphoma: an international phase II study in patients requiring treatment according to GELF/BNLI criteria. J Clin Oncol. 2014 Jan 20;32(3):212-8. doi: 10.1200/JCO.2013.50.3110. Epub 2013 Dec 2.

    PubMed 24297953

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Y Ibritumomab tiuxetan and Rituximab in people with Follicular Lymphoma, run by The Christie NHS Foundation Trust at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Assessed 3 months post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493479, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

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