Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

International Extranodal Lymphoma Study Group (IELSG)

Status and phase

Terminated

Phase 2

Conditions

Lymphoma, B-Cell

Treatments

Drug: Idarubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT00210366

IELSG21

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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