Non-Hodgkin's LymphomaPhase 2NCT00147953
Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab and Total nodal irradiation in people with Non-Hodgkin's Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab and Total nodal irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to not given
- 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
- B-cell non-Hodgkin's lymphoma
- At least one prior antitumor therapy
- ECOG performance status 0-2
- No major organ dysfunction
- Written informed consent
Who cannot join
- The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.
Read the detailed description
Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.
The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab, Total nodal irradiation
- Keywords
- NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Total nodal irradiationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete and partial response rate)
Secondary outcomes (4)
Toxicity
Time to progression
Response duration
Quality-of-Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Engert, Principal investigator, University of CologneR.-P. Mueller, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147953
- Sponsor's protocol ID
- Ritux plus TNI
- Status last verified
- Jan 2010
- First submitted
- 2 Sep 2005
- Last updated
- 27 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00147953
- Acronym / sponsor ID
- Ritux plus TNI
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jun 2004
- First posted
- 7 Sep 2005 (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.
This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.
Detailed description
Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.
The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.
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 (5 listed)
- B-cell non-Hodgkin's lymphoma
- At least one prior antitumor therapy
- ECOG performance status 0-2
- No major organ dysfunction
- Written informed consent
Key exclusion criteria (1 listed)
- The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated 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 |
|---|---|---|
| Rituximab | Drug | – |
| Total nodal irradiation | Procedure or surgery | – |
Primary outcome
Overall response rate (complete and partial response rate)
4 secondary outcomes
Toxicity
Time to progression
Response duration
Quality-of-Life
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 27 Jan 2010.
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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.
Andreas Engert principal investigator
University of Cologne
R.-P. Mueller principal investigator
University of Cologne
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 Rituximab and Total nodal irradiation in people with Non-Hodgkin's Lymphoma, run by University of Cologne 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 5 inclusion and 1 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 27 Jan 2010. 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?
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?
Overall response rate (complete and partial response rate). 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 27 Jan 2010.