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

Lymphoma, High-Grade Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00385125
• Other study ID #: OSHO #73
• Status: Recruiting
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: October 5, 2006
• Start date: August 2004
• Est. completion date: August 2010

Study information

• Verified date: October 2006
• Source: University of Magdeburg
• Contact: Martin Mohren, PD
• Phone: 0049 231 6713266
• Email: martin.mohren[@]medizin.uni-magdeburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, High-Grade

Intervention

Drug:
• Bendamustine

• Rituximab

Locations

Country	Name	City	State
Germany	University of Magdeburg, departement of Hematology and Oncology	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate
Primary	response duration
Secondary	overall survival
Secondary	toxicity