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
Sponsor study identifier
Secondary identifiers
NIH
interventional
160
1 country
1
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 9, 2007
Actual (reported)August 10, 2007
Actual (reported)June 2009
Actual (reported)June 2009
Actual (reported)Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC
3 years
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Arne Kolstad
Oslo, Oslo, 0310, Norway
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.
Arne Kolstad, MD
Nordic Lymphoma Group
Christian Geisler, MD
Nordic Lymphoma Group
Erkki Elonen, MD
Nordic Lymphoma Group
Anna Laurell, MD
Nordic Lymphoma Group
160 participants (actual enrollment reported by the registry).
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
May 4, 2012
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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