Mantle cell lymphoma is a non-Hodgkin lymphoma which is rare and holds a bad prognosis with no known curative therapies available. The lymphoma is most often disseminated at diagnosis.
Conditions
Interventions
Trade Name: Zevalin
Product Name: Zevalin: Yttrium-90 ibritumomab tiuxetan
Pharmaceutical Form: Intravenous infusion
Sponsors
Rikshospitalet-Radiumhospitalet HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically and immunhistologically defined diagnosis of mantle cell lymphoma Previously untreated, except one course of any regimen 18-65 years of age WHO performance status 0-3 Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previously treated for lymphoma Severe medical conditions or infections Pregnancy Other malignancies in the past Severe psyciatric disorders Unwilling or anable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the third Nordic phase II trial in mantle cell lymhoma is to improve the failure-free survivial in pasients who are not in complete remission before transplant by including Zevalin radioimmuntherapy as part of the high-dose regimen before autologous stem cell support.;Secondary Objective: Evaluate safety by including Zevalin in the high-dose regimen Evaluate FFS in patients who are in CR before transplant and thus not receiving Zevalin Evaluate OS in all both patient groups Evaluate TTF in both patient groups Evaluate TTP in both patient groups Evaluate response rates Evaluate molecular response rates Evaluate molecular response and progression-free survival in patients who become PCR positive in bone marrow post-transplant and receive treatment with Rituximab Evaluate lymphoma tissue gene expression profiles and correlate this to outcome;Primary end point(s): Time to treatment failure for pasients receiving not in complete remission prior to transplant and thus receiving Zevalin in addition to the high-dose chemotherapy regimen. A comparisom is to be made to patients included in the previous phase II study, where patients received identical treatment, but without Zevalin. 150 patients have been included in the previoous trial. | — |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed