Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

July 29, 2010 updated by: International Extranodal Lymphoma Study Group (IELSG)

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • IELSG21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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