Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
NCT ID: NCT00210366
Last Updated: 2010-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Idarubicin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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International Extranodal Lymphoma Study Group (IELSG)
OTHER
Responsible Party
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IELSG
Principal Investigators
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Andres JM Ferreri, MD
Role: STUDY_CHAIR
San Raffaele Hospital - HSR Servizio di radiochemioterapia
Locations
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Servizio Radiochemioterapia - Ospedale San Raffaele
Milan, Milan, Italy
Countries
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Related Links
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Click here for more information about this study
Other Identifiers
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IELSG21
Identifier Type: -
Identifier Source: org_study_id