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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC
Arne Kolstad, MD
Nordic Lymphoma Group
Norway: Norwegian Medicines Agency