Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
NCT ID: NCT00385125
Last Updated: 2006-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2004-08-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Bendamustine
Rituximab
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* At least one pretreatment with anthracycline polychemotherapy +/- radiatio:
* first relapse nad contraindication for aggressive salvage therapy e.g. high dose therapy with autologous stem cell transplantation
* second relapse (after aggressive salvage therapy)
* patient's refusal of aggressive salvage therapy in first relapse
* informed consent
Exclusion Criteria
* pretreatment with bendamustine
* primary CNS- lymphoma
* Karnofsky index \< 50 (except caused by lymphoma)
* HIV positive, hepatitis B or C
* serious concurrent disease
* non-compensated heart failure (\>=NYHA 3)
* non-compensated hypertension
* renal insufficiency (creatinine \> 2.0 mg/dl), not related to lymphoma
* hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels \> 200 µmol/l, not related to lymphoma
* missing compliance respective incapability to comply (e.g.cerebral dysfunction
* pregnancy
* hematopoetic insufficiency not lymphoma related (leucocyte count \<= 2500/µl, granulocyte count \<= 1000/µl, platelet count \<= 80000/µl)
18 Years
ALL
No
Sponsors
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University of Magdeburg
OTHER
Principal Investigators
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Martin Mohren, PD
Role: PRINCIPAL_INVESTIGATOR
University of Magdeburg, Department of Hematology and Oncology
Locations
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University of Magdeburg, departement of Hematology and Oncology
Magdeburg, , Germany
Countries
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Central Contacts
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Other Identifiers
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OSHO #73
Identifier Type: -
Identifier Source: org_study_id