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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma, B-Cell
• Intervention / Treatment: Drug: Idarubicin

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Servizio Radiochemioterapia - Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
objective response to treatment

Secondary Outcome Measures

Outcome Measure
overall survival
duration of response
acute side effects of idarubicin

Collaborators and Investigators

• Sponsor: International Extranodal Lymphoma Study Group (IELSG)
• Investigators: Study Chair: Andres JM Ferreri, MD, San Raffaele Hospital - HSR Servizio di radiochemioterapia

Publications and helpful links

Helpful Links

• Click here for more information about this study

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): July 30, 2010
• Last Update Submitted That Met QC Criteria: July 29, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Idarubicin
• Other Study ID Numbers: IELSG21