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AzTrials

Lymphoma, Non-HodgkinPhase 3NCT00185393

Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Treatment in Patients With Follicular Non Hodgkin Lymphoma (Stage III or IV) Having Achieved a Partial or Complete Remission After First Line Chemotherapy

A Phase 3 study testing Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) and no treatment in people with Lymphoma, Non-Hodgkin, run by Bayer at 95 sites in 13 countries.

Completed

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

Official record
Search all trials

Trial summary

The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) and no treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
95 sitesin 13 countries
Study dates
Aug 2001to Feb 2007
Phase
Phase 3
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

  • Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
  • Patients who have achieved a remission after first line chemotherapy
  • No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
  • older than 18 years
  • written informed consent

Who cannot join

  • Any other anticancer treatment for NHL except the preceding first line chemotherapy
  • Prior radiation therapy
  • Patients who have not recovered from the toxic effects of the first line chemotherapy
  • Any other cancer or history of cancer less than 10 years ago
  • Patients with known HIV positivity
  • patients with pleural effusion or ascites
Show all 9Show fewer
  • female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
  • Adults not employing an effective method of birth control during study treatment and 12 months thereafter
  • Patients unable or unwilling to comply with protocol

Trial locations and contacts

95 sites in 13 countries.

95 sites in 13 countries

France14 sites

  • Study site

    Angers, 49033

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33076

  • Study site

    Créteil, 94010

  • Study site

    Grenoble, 38043

  • Study site

    Le Mans, 72000

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69003

  • Study site

    Paris, 75743

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Rennes, Brittany Region, 35038

  • Study site

    Rouen, 76038

  • Study site

    Strasbourg, 67098

  • Study site

    Tours, 37000

Other trials in France

Netherlands13 sites

  • Study site

    Amersfoort, 3800 BM

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Enschede, 7511 JX

  • Study site

    Groningen, 9713 GZ

  • Study site

    Leiden, 2333 ZA

  • Study site

    Maastricht, 6229 HX

  • Study site

    Nijmegen, 6500 HB

  • Study site

    Rotterdam, 3015 GD

  • Study site

    The Hague, 2545 CH

  • Study site

    Utrecht, 3584 CX

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Italy11 sites

  • Study site

    Bologna, BO, 40138

  • Study site

    Milan, MI, 20122

  • Study site

    Milan, MI, 20132

  • Study site

    Milan, 20141

  • Study site

    Naples, 80131

  • Study site

    Palermo, 90146

  • Study site

    Pisa, PI, 56126

  • Study site

    Roma, Roma, 00144

  • Study site

    Rozzano, MI, 20089

  • Study site

    San Giovanni Rotondo, Foggia, 71013

  • Study site

    Torino, TO, 10126

Other trials in Italy

Germany10 sites

  • Study site

    Augsburg, Bavaria, 86156

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Dresden, Saxony, 01309

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Göttingen, Lower Saxony, 37099

  • Study site

    Hamburg, 20099

  • Study site

    Hamm, Nordrhein-Westfalen / 358, 59071

  • Study site

    München, Bavaria, 81675

  • Study site

    Münster, Nordrhein-Westfalen / 298, 48129

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Canada8 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Spain8 sites

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28040

  • Study site

    Málaga, 29010

  • Study site

    Salamanca, 37007

  • Study site

    Valencia, 46010

Other trials in Spain

Switzerland7 sites

  • Study site

    Aarau, 5000

  • Study site

    Bellinzona, 6500

  • Study site

    Bern, 3010

  • Study site

    Geneva, 1211

  • Study site

    Lausanne, 1011

  • Study site

    Sankt Gallen, Saint Gallen / 633, 9007

  • Study site

    Zurich, Bern / 633, 8091

Other trials in Switzerland

United Kingdom7 sites

  • Study site

    Glasgow, G11 6NT

  • Study site

    London, EC1A 7BE

  • Study site

    London, NW3 2PF

  • Study site

    Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, NE1 4LP

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Surrey, SM2 5PT

Other trials in United Kingdom

Belgium6 sites

  • Study site

    Antwerp, 2020

  • Study site

    Bruges, 8000

  • Study site

    Brussels, 1000

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Portugal4 sites

  • Study site

    Coimbra, 3000-076

  • Study site

    Lisbon, 1070-213

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4200-072

Other trials in Portugal

Sweden3 sites

  • Study site

    Gothenburg, 41685

  • Study site

    Umeå, 901 85

  • Study site

    Uppsala, S-751 85

Other trials in Sweden

Denmark2 sites

  • Study site

    Aarhus, DK-8000

  • Study site

    Copenhagen, 2100

Other trials in Denmark

Norway2 sites

  • Study site

    Oslo, 0310

  • Study site

    Tromsø, N-9038

Other trials in Norway

About this study

Official title: Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial

The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.

Read the detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Being tested
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128), no treatment
Keywords
Follicular Non Hodgkin lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

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

  • Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)Biological

    treatment with 90 Yttrium-labeled anti CD 20 antibody

  • no treatmentOther

    no treatment

Study groups in NCT00185393
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
Arm 2OtherNot described
Receives: Other: no treatment

What is being measured

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

  1. Progression free survival

    Measured: End of study

Secondary outcomes (8)

  1. Clinical and molecular response rates

    Measured: End of study

  2. Overall survival

    Measured: End of study

  3. Quality of Life

    Measured: End of study

  4. Adverse events / Toxicity Grading

    Measured: Continous

  5. Clinical laboratory results

    Measured: 3 monthly

  6. Vital signs / physical examination

    Measured: 3 monthly

  7. ECG

    Measured: End of study

  8. Co-medication

    Measured: Continous

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startAug 2001
  3. Study completionFeb 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185393
Sponsor's protocol ID
90966
Other IDs
304820, NHL FIT
Status last verified
Nov 2008
First submitted
12 Sep 2005
Last updated
1 Dec 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) and no treatment in people with Lymphoma, Non-Hodgkin, run by Bayer at 95 sites in 13 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 5 inclusion and 9 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 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in France, Netherlands, Italy, Germany, Canada and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression free survival (time frame: End of study). 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 NCT00185393.

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 1 Dec 2008.

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