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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by University of Magdeburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385125
First Posted: October 6, 2006
Last Update Posted: October 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Magdeburg
  Purpose
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.

Condition Intervention Phase
Lymphoma, High-Grade Drug: Bendamustine Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • response rate
  • response duration

Secondary Outcome Measures:
  • overall survival
  • toxicity

Estimated Enrollment: 30
Study Start Date: August 2004
Estimated Study Completion Date: August 2010
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385125


Contacts
Contact: Martin Mohren, PD 0049 231 6713266 martin.mohren@medizin.uni-magdeburg.de

Locations
Germany
University of Magdeburg, departement of Hematology and Oncology Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Martin Mohren, PD         
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Martin Mohren, PD University of Magdeburg, Department of Hematology and Oncology
  More Information

ClinicalTrials.gov Identifier: NCT00385125     History of Changes
Other Study ID Numbers: OSHO #73
First Submitted: October 5, 2006
First Posted: October 6, 2006
Last Update Posted: October 6, 2006
Last Verified: October 2006

Keywords provided by University of Magdeburg:
relapsed
refractory
CD 20 positive

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action