Back to resultsTreatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
Primary Purpose
Lymphoma, High-Grade
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bendamustine
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, High-Grade focused on measuring relapsed, refractory, CD 20 positive
Eligibility Criteria
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)
Sites / Locations
- University of Magdeburg, departement of Hematology and OncologyRecruiting
Outcomes
Primary Outcome Measures
response rate
response duration
Secondary Outcome Measures
overall survival
toxicity
Full Information
NCT ID
NCT00385125
First Posted
October 5, 2006
Last Updated
October 5, 2006
Sponsor
University of Magdeburg
1. Study Identification
Unique Protocol Identification Number
NCT00385125
Brief Title
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Magdeburg
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, High-Grade
Keywords
relapsed, refractory, CD 20 positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
response rate
Title
response duration
Secondary Outcome Measure Information:
Title
overall survival
Title
toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Mohren, PD
Phone
0049 231 6713266
Email
martin.mohren@medizin.uni-magdeburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Mohren, PD
Organizational Affiliation
University of Magdeburg, Department of Hematology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Magdeburg, departement of Hematology and Oncology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Mohren, PD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
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