High-dose therapy with autologous stem cell support in first line treatment of mantle cell lymphoma - Yttrium-90-ibritutomab tiutexan in combination with BEAM or BEAC to improve outcome for patients not in CR after induction treatment. - Nordic mantle cell lymphoma protocol III
- Conditions
- Mantle cell lymphoma is a rare non-Hodgkin lymphoma (5%) with a bad prognosis with no curative therapies available at present. The disease is most often widely disseminated at diagnosis.
- Registration Number
- EUCTR2005-002003-17-SE
- Lead Sponsor
- ppsala University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Histologically and immunohistochemically defined diagnos 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
Previously treated for lymphoma.
Severe medical conditions or infections.
Pregnancy.
History of other malignancies.
Severe psychiatric disorders.
Unwilling or unable to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method