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Sponsored by: |
Rikshospitalet HF |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00514475 |
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.
Condition | Intervention | Phase |
---|---|---|
Mantle Cell Lymphoma |
Drug: 90Y-ibritumomab tiuxetan (Zevalin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 150 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | June 2014 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contact: Arne Kolstad, MD | +4722934000 | arne.kolstad@radiumhospitalet.no |
Contact: Christian Geisler, MD | +4535451733 | christian.geisler@rh.hosp.dk |
Norway | |
Arne Kolstad | Recruiting |
Oslo, Norway, 0310 | |
Contact: Bente Kvisgaard, Secretary +4722935757 bente.kvisgaard@radiumhospitalet.no | |
Principal Investigator: Arne Kolstad, MD |
Study Chair: | Arne Kolstad, MD | Nordic Lymphoma Group |
Principal Investigator: | Christian Geisler, MD | Nordic Lymphoma Group |
Principal Investigator: | Erkki Elonen, MD | Nordic Lymphoma Group |
Principal Investigator: | Anna Laurell, MD | Nordic Lymphoma Group |
Responsible Party: | The Norwegian Radium Hospital, Oslo, Norway ( Arne Kolstad ) |
Study ID Numbers: | 2005-002003-17 |
Study First Received: | August 9, 2007 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00514475 |
Health Authority: | Norway: Norwegian Medicines Agency |
Mantle cell lymphoma Zevalin 90Y-ibritumomab tiuxetan |
Radioimmunotherapy High-dose therapy First line |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle cell lymphoma Lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |