Treatment protocol for elderly patients with mantle cell lymphoma (MCL). A phase II study of the Finnish Lymphoma Group.
- Conditions
- Mantle cell lymphoma
- Registration Number
- EUCTR2004-003255-39-FI
- Lead Sponsor
- The Finnish Lymphoma group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Inclusion criteria
-Patients with histologically confirmed mantle cell lymphoma
-Advanced stage II-IV
-Previously untreated
-65 years and older, or 55-65 years if not eligible for high dose chemotherapy
-Written informed consent
-Adequate organ function
-PS < 4
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Exclusion criteria
-Severe somatic or psychiatric disease including cardiac, pulmonary, renal and CNS diseases, severe chronic infections, and active malignant diseases
-Poor compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this phase II study is to investigate whether the poor outcome in elderly patients with MCL could be improved by treatment schedule consisting of long induction with combination chemotherapy (alternating CHOP and intermediate-dose cytarabine, plus fludarabine in last three courses) combined with rituximab, and in patients with chemosensitive disease (PR or CR), of maintenance treatment with rituximab. ;Secondary Objective: ;Primary end point(s): Primary: Reduction of lymphoma mass measured by the CR rate, progression-free survival and overall survival <br>Secondary: Progression-free survival and survival after maintenance therapy <br>
- Secondary Outcome Measures
Name Time Method