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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lymphoma, B-Cell

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

objective response to treatment

Principal Investigator

Andres JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Hospital - HSR Servizio di radiochemioterapia

Authority:

Italy: Ministry of Health

Study ID:

IELSG21

NCT ID:

NCT00210366

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Lymphoma, B-Cell
  • Lymphoma
  • Lymphoma, B-Cell

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