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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385125

Enrollment

Registered

2006-10-06

Start date

2004-08-31

Completion date

2010-08-31

Last updated

2006-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, High-Grade

Keywords

relapsed, refractory, CD 20 positive

Brief summary

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.

Interventions

DRUGBendamustine

DRUGRituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
response rate	—
response duration	—

Secondary

Measure	Time frame
overall survival	—
toxicity	—

Countries

Germany

Contacts

Primary ContactMartin Mohren, PD

martin.mohren@medizin.uni-magdeburg.de0049 231 6713266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026