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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Information source: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, B-Cell

Intervention: Idarubicin (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: International Extranodal Lymphoma Study Group (IELSG)

Official(s) and/or principal investigator(s):
Andres JM Ferreri, MD, Study Chair, Affiliation: San Raffaele Hospital - HSR Servizio di radiochemioterapia

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.

Clinical Details

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

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

Primary outcome: objective response to treatment

Secondary outcome:

duration of response

overall survival

acute side effects of idarubicin

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Servizio Radiochemioterapia - Ospedale San Raffaele, Milan 20132, Italy
Additional Information

Click here for more information about this study

Starting date: November 2004
Last updated: July 29, 2010

Page last updated: August 23, 2015

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