Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Lymphoma, B-Cell Clinical Trial

Official title:

Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00210366
• Other study ID #: IELSG21
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 29, 2010
• Start date: November 2004

Study information

• Verified date: July 2010
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• Idarubicin

Locations

Country	Name	City	State
Italy	Servizio Radiochemioterapia - Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response to treatment
Secondary	duration of response
Secondary	overall survival
Secondary	acute side effects of idarubicin

External Links

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