EUCTR2007-005116-12-DE
Active, not recruiting
Phase 1
Phase II study of the mTOR-Inhibitor EVEROLIMUS asmaintenance therapy in patients aged over 60 years with MantleCell Lymphoma (MCL) after first, second, third or fourth linechemotherapyNew title since Protocol Version 4.0Phase II study of the mTOR-Inhibitor EVEROLIMUS asmaintenance therapy in patients aged over 60 years with MantleCell Lymphoma (MCL) after first, second, third or fourth linechemotherapy - CRAD001C2428
Technical University of Munich0 sites0 target enrollmentNovember 5, 2007
DrugsAfinitor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Strategies to prolong remission duration in elderly patients with MCL are urgently needed. The effects of Rapamycin derivates on MCL cells in vitro and the evolving in vivo data support the further investigation of RAD001 in this incurable disease
- Sponsor
- Technical University of Munich
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with a proven history of mantle cell lymphoma
- •2\. Patients with achieved disease control after one to four lines
- •of chemotherapy (complete response, partial response, stable
- •disease) for mantle cell lymphoma.
- •3\. Patients must have been treated with a CHOP\-like
- •chemotherapy or a Fludarabine\-containing regimen
- •previously and Rituximab must have been used as part of the
- •previous treatment.
- •4\. Age \= 60 years or patients \=40 and \<60 years of age who are
- •not eligible for high dose chemotherapy followed by
Exclusion Criteria
- •\- Prior treatment with any investigational drug within the
- •preceding 4 weeks
- •2\. Chronic treatment with systemic steroids or another
- •immunosuppressive agent except for Rituximab.
- •3\. Uncontrolled brain or leptomeningeal disease manifestation,
- •including patients who continue to require glucocorticoids
- •for brain or leptomeningeal disease manifestation
- •4\. Other malignancies within the past 3 years except for
- •adequately treated carcinoma of the cervix or basal or
- •squamous cell carcinomas of the skin.
Outcomes
Primary Outcomes
Not specified
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