Lymphoma, High-GradePhase 2NCT00385125
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
A Phase 2 study testing Bendamustine and Rituximab in people with Lymphoma, High-Grade, run by University of Magdeburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, High-Grade
- What is being tested?
- Bendamustine and Rituximab
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- untreated patients
- pretreatment with bendamustine
- primary CNS- lymphoma
- Karnofsky index < 50 (except caused by lymphoma)
- HIV positive, hepatitis B or C
- serious concurrent disease
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- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Magdeburg, departement of Hematology and Oncology
Magdeburg, 39120
Martin Mohren, PD
About this study
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.
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.
Read the 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.
- Conditions
- Lymphoma, High-Grade
- Being tested
- Bendamustine, Rituximab
- Keywords
- relapsed, refractory, CD 20 positive
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
RituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
response duration
Secondary outcomes (2)
overall survival
toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startAug 2004
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, High-GradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Investigators
- Martin Mohren, PD, Principal investigator, University of Magdeburg, Department of Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385125
- Sponsor's protocol ID
- OSHO #73
- Status last verified
- Oct 2006
- First submitted
- 5 Oct 2006
- Last updated
- 6 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00385125
- Acronym / sponsor ID
- OSHO #73
- Conditions
- Lymphoma, High-Grade
- Keywords
- relapsed, refractory, CD 20 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Aug 2010
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- untreated patients
- pretreatment with bendamustine
- primary CNS- lymphoma
- Karnofsky index < 50 (except caused by lymphoma)
- HIV positive, hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bendamustine | Drug | – |
| Rituximab | Drug | – |
Primary outcome
response rate
response duration
2 secondary outcomes
overall survival
toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Mohren, PD principal investigator
University of Magdeburg, Department of Hematology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine and Rituximab in people with Lymphoma, High-Grade, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Mohren, PD (0049 231 6713266, martin.mohren@medizin.uni-magdeburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2006.