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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00210366
Enrollment
25
Registered
2005-09-21
Start date
2004-11-30
Completion date
Unknown
Last updated
2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, B-Cell

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.

Interventions

DRUGIdarubicin

Sponsors

International Extranodal Lymphoma Study Group (IELSG)
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
objective response to treatment

Secondary

MeasureTime frame
duration of response
overall survival
acute side effects of idarubicin

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026