Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
Information source: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, B-Cell
Intervention: Idarubicin (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: International Extranodal Lymphoma Study Group (IELSG) Official(s) and/or principal investigator(s): Andres JM Ferreri, MD, Study Chair, Affiliation: San Raffaele Hospital - HSR Servizio di radiochemioterapia
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.
Clinical Details
Official title: Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: objective response to treatment
Secondary outcome: duration of responseoverall survival acute side effects of idarubicin
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- 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
Locations and Contacts
Servizio Radiochemioterapia - Ospedale San Raffaele, Milan 20132, Italy
Additional Information
Click here for more information about this study
Starting date: November 2004
Last updated: July 29, 2010
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