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

Phase 2

• Conditions: Lymphoma, High-Grade

• Registration Number: NCT00385125
• Lead Sponsor: University of Magdeburg

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.

Study Timeline

• Study Start: 2004-08
• Status Verified: 2006-10
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-05
• Last Update Submitted: 2006-10-05
• Study First Posted: 2006-10-06
• Last Update Posted: 2006-10-06
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
response rate
response duration

Secondary Outcome Measures

Name	Time	Method
overall survival
toxicity

Trial Locations

Locations (1)

University of Magdeburg, departement of Hematology and Oncology; 🇩🇪 Magdeburg, Germany