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Mantle Cell LymphomaPhase 2NCT00514475

Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma

A Phase 2 study testing 90Y-ibritumomab tiuxetan (Zevalin) in people with Mantle Cell Lymphoma, run by Oslo University Hospital at 1 site in Norway.

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

The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
90Y-ibritumomab tiuxetan (Zevalin)
How many people
160 participants
Where
1 siteNorway
Study dates
Nov 2005to Jun 2009
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 65 years.
  • Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time point of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin-D1 and most cases will have t(11;14) translocation.
  • No previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase II study who can be transferred to NLG-MCL-III before evaluation at week 15.
  • WHO performance status of 0 - 3.
  • Life expectancy of more than 3 months.
  • Written informed consent.

Who cannot join

  • Severe cardiac disease: cardiac function grade 3-4 (Appendix 1).
  • Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
  • Pregnancy/lactation
  • Men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
  • Known HIV positivity
  • Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
  • Known seropositivity for HCV, HbsAg or other active infection uncontrolled by treatment.
  • Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Arne Kolstad

    Oslo, Oslo, 0310

Other trials in Norway

About this study

Official title: High-dose Therapy With Autologous Stem Cell Support in First Line Treatment of Mantle Cell Lymphoma- 90Y-Ibritumomab Tiuxetan in Combination With BEAM or BEAC to Improve Outcome for Patients Not in CR After Induction Treatment

The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy.

Read the detailed description

Mantle cell lymphoma is considered to have the worst outcome of all non-Hodgkins lymphomas. Since 1997, the Nordic Lymphoma Group has conducted phase II studies in order to improve the results for this lymphoma subtype. The first study included high-dose therapy with autologous stem cell support in the first line of treatment. The results showed the importance of a high quality response to pre-transplant induction treatment, and that CHOP-based regimen alone did not achieve this. Thus, the second trial was designed to improve remissions by including Rituximab and high-dose Ara-C. Results now show that a high rate of molecular remission in the bone marrow was achieved, and the 3-year FFS was improved in comparison to the first study (80% vs 24%). Furthermore, patient who had a molecular relapse (t(11;14) or IgV-gene) were treated with 4 doses of Rituximab and many converted back to be PCR negative.

The present and thus third phase II study aims to improve the high-dose regimen by adding Zevalin radioimmunotherapy in patients who are not in CR prior to transplant. Data from the last trial show that patients not in CR at this point have a worse outcome (3 year FFS of 63%, vs 85% for CR patients). Monitoring for molecular relapse in the bone marrow will be done, and patients who become PCR positive will be treated with Rituximab in order to evaluate the value of this strategy.

Being tested
90Y-ibritumomab tiuxetan (Zevalin)
Keywords
Mantle cell lymphoma, Zevalin, 90Y-ibritumomab tiuxetan, Radioimmunotherapy, High-dose therapy, First line
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

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

  • 90Y-ibritumomab tiuxetan (Zevalin)Drug

    90Y-ibritumomab tiuxetan (Zevalin) at 0.4 mCi/kg is administered one week prior to start high-dose chemotherapy (BEAM/BEAC) in patients who have not achieved CR after induction therapy. Predosing with rituximab 250 mg/m2 one weeks prior to radioimmunotherapy and the same day.

What is being measured

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

  1. Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC

    Measured: 3 years

Secondary outcomes (9)

  1. Safety

    Measured: Whole study

  2. TTF for CR patients receiving BEAM/BEAC

    Measured: 3 year

  3. Overall survival

    Measured: 5 year

  4. Time to progression

    Measured: 3 year

  5. Response rates

    Measured: 6 months

  6. Value of PET

    Measured: 6 months

  7. Molecular response rates

    Measured: 6 months

  8. Molecular response and progression-free survival after Rituximab for molecular relapse

    Measured: 5 years

  9. Microarray gene expression analysis

    Measured: 5 years

Timeline

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

  1. First posted10 Aug 2007 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00514475
Sponsor's protocol ID
2005-002003-17
Other IDs
2005
Status last verified
May 2008
First submitted
9 Aug 2007
Last updated
4 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Kolstad A, Laurell A, Jerkeman M, Gronbaek K, Elonen E, Raty R, Pedersen LB, Loft A, Bogsrud TV, Kimby E, Hansen PB, Fagerli UM, Nilsson-Ehle H, Lauritzsen GF, Lehmann AK, Sundstrom C, Karjalainen-Lindsberg ML, Ralfkiaer E, Ehinger M, Delabie J, Bentzen H, Schildt J, Kostova-Aherdan K, Frederiksen H, Brown Pde N, Geisler CH; Nordic Lymphoma Group. Nordic MCL3 study: 90Y-ibritumomab-tiuxetan added to BEAM/C in non-CR patients before transplant in mantle cell lymphoma. Blood. 2014 May 8;123(19):2953-9. doi: 10.1182/blood-2013-12-541953. Epub 2014 Mar 20.

    PubMed 24652994

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 90Y-ibritumomab tiuxetan (Zevalin) in people with Mantle Cell Lymphoma, run by Oslo University Hospital at 1 site in Norway.

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 6 inclusion and 8 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 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC (time frame: 3 years). 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 NCT00514475, 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 4 May 2012.

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