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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

This study has been terminated.
(due to slow accrual)
Information provided by:
International Extranodal Lymphoma Study Group (IELSG) Identifier:
First received: September 13, 2005
Last updated: July 29, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Lymphoma, B-Cell Drug: Idarubicin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

Resource links provided by NLM:

Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • objective response to treatment

Secondary Outcome Measures:
  • duration of response
  • overall survival
  • acute side effects of idarubicin

Estimated Enrollment: 25
Study Start Date: November 2004
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00210366

Servizio Radiochemioterapia - Ospedale San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Study Chair: Andres JM Ferreri, MD San Raffaele Hospital - HSR Servizio di radiochemioterapia
  More Information

Additional Information:
Responsible Party: International Extranodal Lymphoma Study Group, IELSG Identifier: NCT00210366     History of Changes
Other Study ID Numbers: IELSG21
Study First Received: September 13, 2005
Last Updated: July 29, 2010

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017