Non-Hodgkin's LymphomaPhase 3NCT01456351
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
A Phase 3 study testing Bendamustine plus Rituximab and Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by University of Giessen at 1 site in Germany.
Trial summary
The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Bendamustine plus Rituximab and Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2003to Dec 2010
- Phase
- Phase 3
- 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
- Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
- Follicular lymphoma grade 1 and 2
- Immunocytoma and lymphoplasmocytic lymphoma
- Marginal zone lymphoma, nodal and generalised
- Mantle cell lymphoma
- lymphocytic lymphoma (CLL without leucaemic characteristics)
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- non-specified/classified lymphomas of low malignancy
- Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is > 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine
- Need for therapy, except mantle cell lymphomas
- Stadium II (bulky disease, 7.5 cm), II or IV
- Written informed consent
- Performance status WHO 0-2
- Histology not older than 6 months
Who cannot join
- Patients not establishing all above mentioned prerequisites
- Option of a primary, potentially curative radiation therapy
- Patients refractory to Rituximab containing regimens
- Comorbidities excluding a study conform therapy:
- heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma
- Active auto immunohemolytic anemia (AIHA)
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- HIV positive patients
- Active hepatitis infection
- Severe psychiatric diseases
- No compliance or non-compliance to be expected
- Pregnant or breast feeding women
- Anamnestic malignancies or secondary malignancies, not proven
- Cured/curable by surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.
- Conditions
- Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
- Being tested
- Bendamustine plus Rituximab, Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
- Keywords
- Event free survival, Remission rates, Toxicity, Overall survival, Efficiency costs, Recurrent low grade
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine plus RituximabDrug
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4wDrug
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine plus Rituximab | Experimental | Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w Receives: Drug: Bendamustine plus Rituximab |
| Fludarabine plus Rituximab | Active comparator | Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w Receives: Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year
Measured: Observation till event or death, minimum 1 year
Secondary outcomes (1)
Remission Rates
From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year
Measured: Observation till event or death, minimum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2003
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Barth, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456351
- Sponsor's protocol ID
- NHL 2-2003
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2011
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
58. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas - Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2010; 116: 856
81. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas - 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2014; 124:145.
Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. doi: 10.1016/S1470-2045(15)00447-7. Epub 2015 Dec 5.
PubMed 26655425
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
- ClinicalTrials.gov ID
- NCT01456351
- Acronym / sponsor ID
- NHL 2-2003
- Conditions
- Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
- Keywords
- Event free survival, Remission rates, Toxicity, Overall survival, Efficiency costs, Recurrent low grade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Oct 2011 (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.
The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bendamustine plus Rituximab | Experimental | Drug: Bendamustine plus RituximabBendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w |
| Fludarabine plus Rituximab | Active comparator | Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4wFludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
- Follicular lymphoma grade 1 and 2
- Immunocytoma and lymphoplasmocytic lymphoma
- Marginal zone lymphoma, nodal and generalised
- Mantle cell lymphoma
Key exclusion criteria (13 listed)
- Patients not establishing all above mentioned prerequisites
- Option of a primary, potentially curative radiation therapy
- Patients refractory to Rituximab containing regimens
- Comorbidities excluding a study conform therapy:
- heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma
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 plus RituximabBendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles | Drug | Bendamustine plus Rituximab |
| Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4wFludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles | Drug | Fludarabine plus Rituximab |
Primary outcome
Event Free Survival
Time frame: Observation till event or death, minimum 1 year
From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year
1 secondary outcome
Remission Rates
Time frame: Observation till event or death, minimum 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background58. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas - Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2010; 116: 856
- Background81. Rummel MJ et al. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas - 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany) Blood 2014; 124:145.
- Background: PubMed 26655425Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. doi: 10.1016/S1470-2045(15)00447-7. Epub 2015 Dec 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bendamustine plus Rituximab and Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by University of Giessen 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 13 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: finished, as of the sponsor's last update on 22 Aug 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (time frame: Observation till event or death, minimum 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456351, which also lists 3 linked publications.
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 22 Aug 2024.