Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Phase 2

Terminated

• Conditions: Lymphoma, B-Cell

• Registration Number: NCT00210366
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
objective response to treatment

Secondary Outcome Measures

Name	Time	Method
duration of response
overall survival
acute side effects of idarubicin

Trial Locations

Locations (1)

Servizio Radiochemioterapia - Ospedale San Raffaele; 🇮🇹 Milan, Italy