High-dose therapy with autologous stem cell support in first line treatment of mantle cell lymphoma - Yttrium-90-ibritumomab tiuxetan in combination with BEAM or BEAC to improve outcome for patients not in CR after induction treatment. - 3. Mantle cell lymphoma phase II protocol
Phase 1
- Conditions
- 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.
- Registration Number
- EUCTR2005-002003-17-NO
- Lead Sponsor
- Rikshospitalet-Radiumhospitalet HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
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