NCT00514475

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2008

Enrollment Period

3.6 years

First QC Date

August 9, 2007

Last Update Submit

May 3, 2012

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphomaZevalin90Y-ibritumomab tiuxetanRadioimmunotherapyHigh-dose therapyFirst line

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (9)

  • Safety

    Whole study

  • TTF for CR patients receiving BEAM/BEAC

    3 year

  • Overall survival

    5 year

  • Time to progression

    3 year

  • Response rates

    6 months

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arne Kolstad

Oslo, Oslo County, 0310, Norway

Location

Related Publications (1)

  • 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.

    PMID: 24652994DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Arne Kolstad, MD

    Nordic Lymphoma Group

    STUDY CHAIR

  • Christian Geisler, MD

    Nordic Lymphoma Group

    PRINCIPAL INVESTIGATOR

  • Erkki Elonen, MD

    Nordic Lymphoma Group

    PRINCIPAL INVESTIGATOR

  • Anna Laurell, MD

    Nordic Lymphoma Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

November 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 4, 2012

Record last verified: 2008-05

Locations

NO(1)