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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210366
Recruitment Status : Terminated (due to slow accrual)
First Posted : September 21, 2005
Last Update Posted : July 30, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: Idarubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Study Start Date : November 2004
Actual Primary Completion Date : July 2010

Primary Outcome Measures :
  1. objective response to treatment

Secondary Outcome Measures :
  1. duration of response
  2. overall survival
  3. acute side effects of idarubicin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210366

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Servizio Radiochemioterapia - Ospedale San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
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Study Chair: Andres JM Ferreri, MD San Raffaele Hospital - HSR Servizio di radiochemioterapia
Additional Information:
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Responsible Party: International Extranodal Lymphoma Study Group, IELSG Identifier: NCT00210366    
Other Study ID Numbers: IELSG21
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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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