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Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL

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ClinicalTrials.gov Identifier: NCT00385125
Recruitment Status : Unknown
Verified October 2006 by University of Magdeburg.
Recruitment status was:  Recruiting
First Posted : October 6, 2006
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
University of Magdeburg

October 5, 2006
October 6, 2006
October 6, 2006
August 2004
Not Provided
  • response rate
  • response duration
Same as current
No Changes Posted
  • overall survival
  • toxicity
Same as current
Not Provided
Not Provided
 
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.
Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation.
Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation. Aim is to find response rates and duration of combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD 20 positive B cell NHL.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, High-Grade
  • Drug: Bendamustine
  • Drug: Rituximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
August 2010
Not Provided

Inclusion Criteria:

  • Histologically proven high grade B-NHL (CD 20 >= 20 % positive)
  • 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:

  • untreated patients
  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00385125
OSHO #73
Not Provided
Not Provided
Not Provided
Not Provided
University of Magdeburg
Not Provided
Principal Investigator: Martin Mohren, PD University of Magdeburg, Department of Hematology and Oncology
University of Magdeburg
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP