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

NCT ID: NCT00385125

Last Updated: 2006-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, High-Grade

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

relapsed refractory CD 20 positive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bendamustine

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Magdeburg

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Mohren, PD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg, Department of Hematology and Oncology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Magdeburg, departement of Hematology and Oncology

Magdeburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martin Mohren, PD

Role: CONTACT

Phone: 0049 231 6713266

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OSHO #73

Identifier Type: -

Identifier Source: org_study_id