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

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 II

MedlinePlus related topics:

Lymphoma

Drug Information available for:

Rituximab Bendamustine Bendamustine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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.

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

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

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

Keywords provided by University of Magdeburg:

relapsed

refractory

CD 20 positive

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Rituximab

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Aggression

Lymphoma

Bendamustine

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	University of Magdeburg
Information provided by:	University of Magdeburg
ClinicalTrials.gov Identifier:	NCT00385125