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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Primary Purpose

Lymphoma, B-Cell

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Idarubicin
Sponsored by
International Extranodal Lymphoma Study Group (IELSG)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Servizio Radiochemioterapia - Ospedale San Raffaele

Outcomes

Primary Outcome Measures

objective response to treatment

Secondary Outcome Measures

duration of response
overall survival
acute side effects of idarubicin

Full Information

First Posted
September 13, 2005
Last Updated
July 29, 2010
Sponsor
International Extranodal Lymphoma Study Group (IELSG)
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1. Study Identification

Unique Protocol Identification Number
NCT00210366
Brief Title
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
Official Title
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
due to slow accrual
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International Extranodal Lymphoma Study Group (IELSG)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Idarubicin
Primary Outcome Measure Information:
Title
objective response to treatment
Secondary Outcome Measure Information:
Title
duration of response
Title
overall survival
Title
acute side effects of idarubicin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres JM Ferreri, MD
Organizational Affiliation
San Raffaele Hospital - HSR Servizio di radiochemioterapia
Official's Role
Study Chair
Facility Information:
Facility Name
Servizio Radiochemioterapia - Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.ielsg.org
Description
Click here for more information about this study

Learn more about this trial

Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

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