Lymphoma, B-CellPhase 2NCT00210366
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
A Phase 2 study testing Idarubicin in people with Lymphoma, B-Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Italy.
Trial summary
The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Idarubicin
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2004to Jul 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of non-Hodgkin's lymphoma
- Disease exclusively localised into the CNS at first diagnosis and failure
- Progressive or recurrent disease
- Previous treatment with HDMTX containing CHT and/or RT
- Presence of at least one target lesion, bidimensionally measurable
- Age 18 - 75 years
Show all 18Show fewer
- ECOG performance status < 3 (Appendix 1).
- No known HIV disease or immunodeficiency
- HBsAg-negative and Ab anti-HCV-negative patients.
- Adequate bone marrow function (plt > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3)
- Adequate renal function (serum creatinine < 2 times UNL)
- Adequate hepatic function (SGOT/SGPT < 3 times UNL, bilirubin and alkaline phosphatase < 2 times UNL)
- Adequate cardiac function (VEF ≥ 50%)
- Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
- No concurrent treatment with other experimental drugs.
- Informed consent signed by the patient before registration
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Servizio Radiochemioterapia - Ospedale San Raffaele
Milan, Milan, 20132
About this study
Official title: Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.
- Conditions
- Lymphoma, B-Cell
- Being tested
- Idarubicin
- 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.
IdarubicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response to treatment
Secondary outcomes (3)
duration of response
overall survival
acute side effects of idarubicin
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)
- Study startNov 2004
- Primary completionJul 2010
Why it stopped: due to slow 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Investigators
- Andres JM Ferreri, MD, Study chair, San Raffaele Hospital - HSR Servizio di radiochemioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210366
- Sponsor's protocol ID
- IELSG21
- Status last verified
- Jul 2010
- First submitted
- 13 Sep 2005
- Last updated
- 30 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
- ClinicalTrials.gov ID
- NCT00210366
- Acronym / sponsor ID
- IELSG21
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow accrual
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jul 2010 (actual)
- 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 main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histological or cytological diagnosis of non-Hodgkin's lymphoma
- Disease exclusively localised into the CNS at first diagnosis and failure
- Progressive or recurrent disease
- Previous treatment with HDMTX containing CHT and/or RT
- Presence of at least one target lesion, bidimensionally measurable
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 |
|---|---|---|
| Idarubicin | Drug | – |
Primary outcome
objective response to treatment
3 secondary outcomes
duration of response
overall survival
acute side effects of idarubicin
Results and safety
The study was stopped early (reason given: due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
- Click here for more information about this studyLink 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.
Andres JM Ferreri, MD study chair
San Raffaele Hospital - HSR Servizio di radiochemioterapia
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 Idarubicin in people with Lymphoma, B-Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Italy.
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 18 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: stopped early, as of the sponsor's last update on 30 Jul 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 Italy. 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 was stopped early (reason given: due to slow accrual). Results are not available in the source record.
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?
objective response to treatment. 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 Jul 2010.