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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

This study has been terminated.
(due to slow accrual)
Sponsor:
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210366
First received: September 13, 2005
Last updated: July 29, 2010
Last verified: July 2010
History of Changes

September 13, 2005
July 29, 2010
November 2004
July 2010   (final data collection date for primary outcome measure)
objective response to treatment
Same as current
Complete list of historical versions of study NCT00210366 on ClinicalTrials.gov Archive Site
  • duration of response
  • overall survival
  • acute side effects of idarubicin
  • -duration of response
  • -overall survival
  • -acute side effects of idarubicin
Not Provided
Not Provided
 
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell
Drug: Idarubicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00210366
IELSG21
Not Provided
International Extranodal Lymphoma Study Group, IELSG
International Extranodal Lymphoma Study Group (IELSG)
Not Provided
Study Chair: Andres JM Ferreri, MD San Raffaele Hospital - HSR Servizio di radiochemioterapia
International Extranodal Lymphoma Study Group (IELSG)
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP