B-cell LymphomaPhase 1/2HITTNCT00761384
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma
A Phase 1/2 study testing 90Y-ibritumomab in people with B-cell Lymphoma, run by Lund University Hospital at 1 site in Sweden.
Trial summary
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma
- What is being tested?
- 90Y-ibritumomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Jan 2016
- Phase
- Phase 1/2
- 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
- Written informed concent
- Age at least 18 years
- WHO Performance status 0-3
- Histologically verified B-cell lymphoma
- Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (HDCT) with stem cell support or radiotherapy
- Transformed B-cell lymphoma, failing first line therapy and not suitable for high dose chemotherapy (HDCT) or with a history of HDCT with stem cell support
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- Follicular lymphoma grade II and I, and other indolent lymphomas must have failed second line treatment.
- One of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance.
- The lymphoma must require treatment, Mantle cell lymphoma, failing first line treatment,treatment required
- Measurable disease and the tumor burden must be acceptable according to the investigator
- Radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment
- Bone marrow reserve likely to give a harvest of at least 2x10 6 peripheral CD34+ stemcells or the existence of such a harvest or a corresponding central harvest
- Total bilirubin should not exceed 40 micromole/L
- A GFR as measured by Cystatin C of 50 ml/min
- HIV, Hepatitis B and C status known
- Life expectancy of at least 3 months.
Who cannot join
- Known or clinical evidence of CNS involvement
- Bone marrow involvement at harvest as measured by biopsy and flow cytometry
- Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys
- Prior chemotherapy or radiotherapy within 4 weeks
- Subjects who are pregnant or nursing
- Pulmonary involvement, that is not negligible at the discretion of the investigator
- Liver involvement of lymphoma
- History of hepatitis B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study With Individually Adjusted High Dose 90Y-Ibritumomab Tiuxetan Treatment With Peripheral Blood Stem Cells Support to Improve Outcome for Patients With Refractory/Recurrent B-cell Lymphoma, Stage II-IV
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
- Conditions
- B-cell Lymphoma
- Being tested
- 90Y-ibritumomab
- Keywords
- B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study
- Medical subject headings
- Lymphoma, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-ibritumomabDrug
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
| Study group | Role | What they receive |
|---|---|---|
| 90Y-ibritumomab | Experimental | 90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver. Receives: Drug: 90Y-ibritumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)
Measured: 5 years
Secondary outcomes (1)
Overall response (OR), complete response (CR), their duration, absorbed dose to normal organ and tumours, relapse pattern, the effect of radioimmunotherapy (RIT) in its own right as assessed by positron emission tomography (PET)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Ola Lindén, MD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761384
- Sponsor's protocol ID
- 6th radioimmunotherapy prot.
- Other IDs
- EudraCT number: 2007-002762-35
- Acronym
- HITT
- Status last verified
- Apr 2015
- First submitted
- 26 Sep 2008
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study With Individually Adjusted High Dose 90Y-Ibritumomab Tiuxetan Treatment With Peripheral Blood Stem Cells Support to Improve Outcome for Patients With Refractory/Recurrent B-cell Lymphoma, Stage II-IV
- ClinicalTrials.gov ID
- NCT00761384
- Acronym / sponsor ID
- HITT / 6th radioimmunotherapy prot.
- Conditions
- B-cell Lymphoma
- Keywords
- B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Sep 2008 (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.
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 90Y-ibritumomab | Experimental | Drug: 90Y-ibritumomab90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed concent
- Age at least 18 years
- WHO Performance status 0-3
- Histologically verified B-cell lymphoma
- Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (HDCT) with stem cell support or radiotherapy
Key exclusion criteria (8 listed)
- Known or clinical evidence of CNS involvement
- Bone marrow involvement at harvest as measured by biopsy and flow cytometry
- Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys
- Prior chemotherapy or radiotherapy within 4 weeks
- Subjects who are pregnant or nursing
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 |
|---|---|---|
| 90Y-ibritumomab90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver. | Drug | 90Y-ibritumomab |
Primary outcome
Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)
Time frame: 5 years
1 secondary outcome
Overall response (OR), complete response (CR), their duration, absorbed dose to normal organ and tumours, relapse pattern, the effect of radioimmunotherapy (RIT) in its own right as assessed by positron emission tomography (PET)
Time frame: 5 years
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 19 Feb 2016.
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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.
Ola Lindén, MD principal investigator
Lund University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 90Y-ibritumomab in people with B-cell Lymphoma, run by Lund University Hospital at 1 site in Sweden.
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 16 inclusion and 8 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 19 Feb 2016. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF) (time frame: 5 years). 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 19 Feb 2016.