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Follicular LymphomaPhase 2NCT00772655

Zevalin® First Line in Follicular Lymphoma

A Phase 2 study testing 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab and Rituximab in people with Follicular Lymphoma, run by Charite University, Berlin, Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2007to Jun 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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient > 50 years old
  • Follicular lymphoma grade I, II, or IIIa according to REAL/WHO classification
  • Ann Arbor stage III, or IV, or stage II with disseminated abdominal disease requiring extensive abdominal irradiation
  • No prior chemotherapy, immunotherapy, or irradiation. Furthermore, when receiving therapy as part of this "Zevalin® first line in follicular lymphoma" trial and up to six months after therapy has ended, patients may not participate in another clinical trial. If patients receive consolidation therapy with Rituximab, the six months period is counted from the end of the consolidation therapy.
  • Lymphoma cells positive for CD20
  • Measurable disease (two perpendicular diameters by either physical or radiological examination)
  • WHO/ECOG performance status 0 - 2
  • Written informed consent

Who cannot join

  • Bone marrow involvement only
  • Bone marrow infiltration > 25%
  • Leukocytopenia < 2.500 /µl
  • Thrombocytopenia < 100.000 /µl
  • Bulk lesions > 10 cm
  • CNS lymphoma manifestation
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  • Circulating tumor cells > 500 /µl
  • Extensive pleural effusion/ascites (> 1000 ml as estimated by ultrasound/CT)
  • Severe concomitant diseases (e.g. congestive heart failure, myocardial infarction within 6 months of study, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease, liver disease)
  • Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN) (unless caused by the lymphoma)
  • Abnormal renal function: serum creatinine > 2 x upper limit of normal (unless caused by the lymphoma)
  • Previous malignancy other than non-melanoma skin cancer
  • Pregnant or breast feeding female patients (negative pregnancy test required for women of fertile age), no effective contraception
  • HIV positivity
  • Known hypersensitivity to foreign proteins, murine antibodies, presence of human anti-murine antibodies (HAMA) reactivity
  • Severe psychiatric illness

About this study

Official title: Multicenter European Pilot Study of 90Yttrium-Ibritumomab Tiuxetan as First Line Therapy for Stage III - IV Follicular Lymphoma (and Selected Patients With Extended Stage II) Followed by Consolidation Rituximab for Patients in Complete Remission But With Persistent Molecular Disease

This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.

Read the detailed description

Only patients requiring treatment (B-symptoms, lymphoma progression > 50% within an observation period of 6 months or less, organ compression by lymphoma or bulky disease as defined by lesions above 5 cm on one axis) may enter the study.

Being tested
90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab, Rituximab
Keywords
Follicular Lymphoma, First line therapy, Zevalin, 90Yttrium-Ibritumomab Tiuxetan, Yttrium, Rituximab, Radio-immuno therapy
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+RituximabDrug

    Also called Zevalin®, Mabthera®

    A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 [if platelets are below 150000/µl only 11 MBq/kg are administered).

  • RituximabDrug

    Also called Mabthera®

    Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2-positivity 6 months after 90Y-Ibritumomab Tiuxetan.

Study groups in NCT00772655
Study groupRoleWhat they receive
Study TherapyExperimentalInduction therapy with a single course of 90Yttrium-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111Indium-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 up to a maximal dose of 12.000 MBq [if platelets are below 150000/µl only 11 MBq/kg are administered). Observation for patients achieving complete clinical and molecular response or partial clinical response. Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2 (t14;18)-positivity 6 months after 90Y-Ibritumomab Tiuxetan.
Receives: Drug: 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab; Drug: Rituximab

What is being measured

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

  1. Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan

    Measured: 6 months from entry onto trial

Secondary outcomes (3)

  1. Time to progression after treatment with 90Y-Ibritumomab Tiuxetan

    Measured: 5 years from entry onto trial

  2. Ability of consolidation therapy with Rituximab to induce molecular remission for CR patients not achieving molecular remission within 6 months after 90Y-Ibritumomab Tiuxetan

    Measured: 5 years from entry onto trial

  3. Safety and tolerability of 90Y-Ibritumomab Tiuxetan with particular respect to further therapy strategies in relapsed patients

    Measured: 5 years from entry onto trial

Timeline

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

  1. First posted15 Oct 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJun 2010
  4. Study completionJun 2015 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00772655
Sponsor's protocol ID
EudraCT-No.:2006-005778-34
Other IDs
PEI-No.: 364/01, BFS-No.: 22461/2-2007-001
Status last verified
Jul 2012
First submitted
14 Oct 2008
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Rieger K, De Filippi R, Linden O, Viardot A, Hess G, Lerch K, Neumeister P, Stroux A, Peuker CA, Pezzutto A, Pinto A, Keller U, Scholz CW. 90-yttrium-ibritumomab tiuxetan as first-line treatment for follicular lymphoma: updated efficacy and safety results at an extended median follow-up of 9.6 years. Ann Hematol. 2022 Apr;101(4):781-788. doi: 10.1007/s00277-022-04781-3. Epub 2022 Feb 12.

    PubMed 35150296

  • Scholz CW, Pinto A, Linkesch W, Linden O, Viardot A, Keller U, Hess G, Lastoria S, Lerch K, Frigeri F, Arcamone M, Stroux A, Frericks B, Pott C, Pezzutto A. (90)Yttrium-ibritumomab-tiuxetan as first-line treatment for follicular lymphoma: 30 months of follow-up data from an international multicenter phase II clinical trial. J Clin Oncol. 2013 Jan 20;31(3):308-13. doi: 10.1200/JCO.2011.41.1553. Epub 2012 Dec 10.

    PubMed 23233718

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab and Rituximab in people with Follicular Lymphoma, run by Charite University, Berlin, Germany.

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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan (time frame: 6 months from entry onto trial). 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 NCT00772655, which also lists 2 linked publications.

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 2 Aug 2012.

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