Non Hodgkin's LymphomaPhase 2NCT00834951
Adjuvant Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Low dose total body irradiation in people with Non Hodgkin's Lymphoma, run by University of Aarhus.
Trial summary
The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Non Hodgkin's Lymphoma
- What is being tested?
- Low dose total body irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2008
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count.
Who cannot join
- Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.
About this study
Official title: A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy
- Conditions
- Non Hodgkin's Lymphoma
- Being tested
- Low dose total body irradiation
- Keywords
- Diffuse large B-cell lymphoma, Elderly patients, Low dose total body irradiation, RCHOP14
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose total body irradiationRadiation
Low dose total body irradiation is given 3 weeks after the end of chemo-immunetherapy in the form of 4 daily fractions 0.2 Gy per fraction to be repeated after 2 weeks of rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2003
- Primary completionDec 2007
- Study completionDec 2008
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834951
- Sponsor's protocol ID
- LTBI-NHL-01
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00834951
- Acronym / sponsor ID
- LTBI-NHL-01
- Conditions
- Non Hodgkin's Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Elderly patients, Low dose total body irradiation, RCHOP14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Feb 2009 (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 purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count.
Key exclusion criteria (1 listed)
- Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.
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 |
|---|---|---|
| Low dose total body irradiationLow dose total body irradiation is given 3 weeks after the end of chemo-immunetherapy in the form of 4 daily fractions 0.2 Gy per fraction to be repeated after 2 weeks of rest | Radiation | – |
Primary outcome
Not reported in the source record.
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 3 Feb 2009.
Related trials for Non Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose total body irradiation in people with Non Hodgkin's Lymphoma, run by University of Aarhus.
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 1 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 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 3 Feb 2009.