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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University of Magdeburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00385125
First received: October 5, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00385125     History of Changes
Other Study ID Numbers: OSHO #73
Study First Received: October 5, 2006
Last Updated: October 5, 2006
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 21, 2014