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

NCT00385125 | Unknown Phase 2

• 1 other identifier: OSHO #73
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, High-Grade

Keywords

relapsed; refractory; CD 20 positive

Outcome Measures

Primary Outcomes (2)

• response rate

• response duration

Secondary Outcomes (2)

• overall survival

• toxicity

Interventions

Bendamustine DRUG

Rituximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Magdeburg: lead

Study Sites (1)

University of Magdeburg, departement of Hematology and Oncology

Magdeburg, 39120, Germany

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Martin Mohren, PD

  University of Magdeburg, Department of Hematology and Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Mohren, PD

CONTACT

0049 231 6713266; martin.mohren@medizin.uni-magdeburg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: August 1, 2004
• Study Completion: August 1, 2010
• Last Updated: October 6, 2006

Record last verified: 2006-10

Locations

DE (1)