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Clinical Trials/EUCTR2009-012432-32-DE
EUCTR2009-012432-32-DE
Active, not recruiting
Phase 1

RANDOMIZED PHASE II TRIAL ON PRIMARY CHEMOTHERAPY WITH HIGH-DOSE METHOTREXATE AND HIGH-DOSE CYTARABINE WITH OR WITHOUT THIOTEPA, AND WITH OR WITHOUT RITUXIMAB, FOLLOWED BY BRAIN IRRADIATION vs. HIGH-DOSE CHEMOTHERAPY SUPPORTED BY AUTOLOGOUS STEM CELLS TRANSPLANTATION FOR IMMUNOCOMPETENT PATIENTS WITH NEWLY DIAGNOSED PRIMARY CNS LYMPHOMA - IELSG

niversity Medical Center Freiburg Dept. Klinikum Stuttgart, Stuttgart Cancer Center0 sites200 target enrollmentMay 11, 2010
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Medical Center Freiburg Dept. Klinikum Stuttgart, Stuttgart Cancer Center
Enrollment
200
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 11, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity Medical Center Freiburg Dept. Klinikum Stuttgart, Stuttgart Cancer Center

Eligibility Criteria

Inclusion Criteria

  • •Histological or cytological assessed diagnosis of non\-Hodgkin's lymphoma.
  • •Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
  • •Disease exclusively localized into the central nervous system, CSF, cranial nerves or eyes.
  • •At least one measurable lesion.
  • •Previously untreated patients (previous or ongoing steroid therapy admitted).
  • •Age 18\-65 years (with ECOG Performance Status 0\-3\) or 66\-70 (with ECOG Performance Status 0\-2\).
  • •Adequate bone marrow (PLT \= 100000 mm3, Hb ? 9 g/dl, ANC ? 2\.000 mm3\), renal (creatinine clearance ? 60 ml/min), cardiac (VEF ? 50%), and hepatic function (total serum bilirubin \= 3 mg/dL, AST/ALT and ?GT \= 2 per upper normal limit value).
  • •Sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation.
  • •Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule.
  • •Patient\-signed informed consent obtained before registration.

Exclusion Criteria

  • •Patients with lymphomatous lesions outside the CNS.
  • •Patients with a previous non\-Hodgkin lymphoma at any time.
  • •Previous or concurrent malignancies with the exception of surgically cured carcinoma in\-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years.
  • •HBsAg and HCV positivity.
  • •HIV infection, previous organ transplantation or other clinically evident form of immunodeficiency.
  • •Concurrent treatment with other experimental drugs.
  • •Concurrent Pregnancy or lactation.
  • •Patients not agreeing to take adequate contraceptive measures during the study.
  • •Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease).

Outcomes

Primary Outcomes

Not specified

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