Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514475
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2007-08-09
Brief Title:
Zevalin-BEAMBEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 t1114 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None