Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
This study has been terminated.
(due to slow accrual)
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210366
First received: September 13, 2005
Last updated: July 29, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell |
Drug: Idarubicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas |
Resource links provided by NLM:
Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):
Primary Outcome Measures:
- objective response to treatment
Secondary Outcome Measures:
- duration of response
- overall survival
- acute side effects of idarubicin
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2004 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210366
Locations
| Italy | |
| Servizio Radiochemioterapia - Ospedale San Raffaele | |
| Milan, Italy, 20132 | |
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
| Study Chair: | Andres JM Ferreri, MD | San Raffaele Hospital - HSR Servizio di radiochemioterapia |
More Information
Additional Information:
No publications provided
| Responsible Party: | International Extranodal Lymphoma Study Group, IELSG |
| ClinicalTrials.gov Identifier: | NCT00210366 History of Changes |
| Other Study ID Numbers: | IELSG21 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 29, 2010 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Idarubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013