Lymphoma, B CellPhase 1NCT00210340
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis
A Phase 1 study testing intrathecal rituximab in people with Lymphoma, B Cell, run by International Extranodal Lymphoma Study Group (IELSG).
Trial summary
The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B Cell
- What is being tested?
- intrathecal rituximab
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
- Pathologically diagnosed CD20-positive NHL
- Age ≥ 18 years
- ECOG Performance Status 0 - 2 (See Appendix A)
- Life expectancy of at least 1 month
- Informed consent must be given according to national/local regulations before enrollment (See Appendix B)
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- Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or thiotepa for treatment of lymphomatous meningitis but these treatments must have completed at least two weeks before the study enrollment and the patients must have recovered from any reversible toxicity caused by prior treatments
- Concurrent systemic chemotherapy is allowed with the exception of high-dose methotrexate (>500 mg/m2/day), high-dose cytarabine (>2 g/m2/day), high-dose thiotepa (>300 mg/m2/day) or investigational agents
- No concurrent intrathecal chemotherapy other than rituximab
- No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless due to proven lymphoma involvement
- No major impairment of renal function (serum creatinine < 1,5 x upper normal) or liver function (ASAT/ALAT < 2,5 upper normal, total bilirubin <2,5x upper normal), unless due to proven lymphoma involvement
- No evidence of active opportunistic infections
- No HIV infection
- No pregnant or lactating status
- Appropriate contraceptive method in women of childbearing potential or men
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.
Who cannot join
None listed.
About this study
The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.
- Conditions
- Lymphoma, B Cell
- Being tested
- intrathecal rituximab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal rituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of rituximab given intrathecally
Secondary outcomes (3)
preliminary evaluation of the antitumor activity of i.t. rituximab
collection of CSF samples devoted to ancillary biological studies
pharmacokinetics of different dose levels of intrathecal rituximab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B CellStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Investigators
- Annarita Conconi, MD, Study chair, International Extranodal Lymphoma Study Group/Hematology Division. University Amedeo Avogadro. NovaraAndres JM Ferreri, MD, Study chair, Radiochemotherapy San Raffaele Hospital. Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210340
- Sponsor's protocol ID
- IELSG24
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis
- ClinicalTrials.gov ID
- NCT00210340
- Acronym / sponsor ID
- IELSG24
- Conditions
- Lymphoma, B Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- First posted
- 21 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.
The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.
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 (17 listed)
- Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
- Pathologically diagnosed CD20-positive NHL
- Age ≥ 18 years
- ECOG Performance Status 0 - 2 (See Appendix A)
- Life expectancy of at least 1 month
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| intrathecal rituximab | Drug | – |
Primary outcome
Safety profile of rituximab given intrathecally
3 secondary outcomes
preliminary evaluation of the antitumor activity of i.t. rituximab
collection of CSF samples devoted to ancillary biological studies
pharmacokinetics of different dose levels of intrathecal rituximab
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Click here for more information about this study: phase I study of intrathecal rituximab in patients with lymphomatous meningitisLink provided by the sponsor.
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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.
Annarita Conconi, MD study chair
International Extranodal Lymphoma Study Group/Hematology Division. University Amedeo Avogadro. Novara
Andres JM Ferreri, MD study chair
Radiochemotherapy San Raffaele Hospital. Milan
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intrathecal rituximab in people with Lymphoma, B Cell, run by International Extranodal Lymphoma Study Group (IELSG).
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 17 inclusion and 0 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: withdrawn, as of the sponsor's last update on 30 Mar 2015. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety profile of rituximab given intrathecally. 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 30 Mar 2015.