Freiburg ZNS-NHL Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00647049
First received: March 26, 2008
Last updated: November 16, 2009
Last verified: November 2009

March 26, 2008
November 16, 2009
January 2007
May 2013   (final data collection date for primary outcome measure)
Complete response rate [ Time Frame: 30 days after blood stem cell transplantation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647049 on ClinicalTrials.gov Archive Site
  • Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
  • Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ]
  • Neuropsychological state according to Mini-Mental State [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ]
  • Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20) [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ]
  • (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Freiburg ZNS-NHL Study
Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation

The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Non Hodgkin Lymphoma of the Central Nervous System
  • Drug: methotrexate
    8000mg/m2 i.v., max. 2 cycles
    Other Name: MTX
  • Drug: Rituximab
    375mg/m2, max. 8 times
  • Drug: Cytarabine
    3000mg/m2 die i.v., 2 days (max. 2 cycles)
    Other Name: Arabinoside
  • Drug: Thiotepa
    40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
  • Drug: Carmustin
    400mg/m2 i.v. for 1 day
    Other Names:
    • BCNU
    • Bis-Chlorethyl-Nitrosourea
  • Experimental: A
    first diagnosis of PCNSL: combined chemotherapy with methotrexate
    Interventions:
    • Drug: methotrexate
    • Drug: Rituximab
    • Drug: Cytarabine
    • Drug: Thiotepa
    • Drug: Carmustin
  • Experimental: B
    Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
    Interventions:
    • Drug: Rituximab
    • Drug: Cytarabine
    • Drug: Thiotepa
    • Drug: Carmustin
Illerhaus G, Marks R, Ihorst G, Guttenberger R, Ostertag C, Derigs G, Frickhofen N, Feuerhake F, Volk B, Finke J. High-dose chemotherapy with autologous stem-cell transplantation and hyperfractionated radiotherapy as first-line treatment of primary CNS lymphoma. J Clin Oncol. 2006 Aug 20;24(24):3865-70. Epub 2006 Jul 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
August 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • group A: first diagnosis of PCNSL, histologically confirmed
  • group B: relapse or progression of PCNSL after MTX containing chemotherapy
  • age 18 - 65 years
  • not legally incompetent, physically or mentally incapable of giving consent
  • written signed and dated informed consent of the legal representative and - if possible - of the patient

Exclusion Criteria:

  • manifestations of further lymphoma outside the CNS
  • sero-positive for HIV
  • severe pulmonary, cardiac, hepatic, renal impairment
  • neutrophil count < 2.000/µl, platelet count < 100.000/µl
  • pulmonary disease with IVC < 55%, DLCO < 40%
  • cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
  • creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
  • bilirubin > 2mg/dl
  • ascites or pleural effusion (> 500ml)
  • pregnancy o r lactation
  • women with childbearing potential without sufficient contraception
  • participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
  • known or current drug or alcohol abuse
  • known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
Both
18 Years to 65 Years
No
Contact: Gerald Illerhaus, Dr. 00497612703785 Gerald.Illerhaus@uniklinik-freiburg.de
Contact: Andreas Zähringer, Dr. 00497612707370 andreas.zaehringer@uniklinik-freiburg.de
Germany
 
NCT00647049
ZNS-00465
No
Dr. G. Illerhaus, University Hospital Freiburg
University Hospital Freiburg
University Hospital Tuebingen
Principal Investigator: Jürgen Finke, Prof. Dr. University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
University Hospital Freiburg
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP