Status:
UNKNOWN
High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an ...
Eligibility Criteria
Inclusion
- highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
- CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
- ECOG performance score ≤2
- no active infection
- negative HIV-serology
- adequate renal function (creatinine clearance \> 50 ml/min)
- adequate bone marrow function (granulocytes \>1500/μl, platelets \> 80000/μl)
- normal bilirubin, AST \< 3 x UNL
- negative pregnancy test
Exclusion
- newly diagnosed NHL with primary CNS involvement
- indolent NHL, lymphoblastic NHL or Burkitt lymphoma
- preceding CNS irradiation
- pretreatment of CNS relapse other than corticosteroids
- immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
- second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
- unfit to receive an intensive chemotherapy
- pregnancy or breastfeeding
- known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01148173
Start Date
October 1 2007
End Date
October 1 2012
Last Update
June 22 2010
Active Locations (1)
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1
Charité Universitätsmedizin
Berlin, State of Berlin, Germany, 12200