We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Freiburg ZNS-NHL Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00647049
Recruitment Status : Unknown
Verified November 2009 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : March 31, 2008
Last Update Posted : November 17, 2009
Information provided by:

March 26, 2008
March 31, 2008
November 17, 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 ]
Same as current
Complete list of historical versions of study NCT00647049 on ClinicalTrials.gov Archive Site
  • Duration of response [ Time Frame: within 5 years ]
  • Overall survival time [ Time Frame: within 5 years ]
  • Neuropsychological state according to Mini-Mental State [ Time Frame: within 5 years ]
  • 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 ]
  • (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ]
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
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
    • Drug: methotrexate
    • Drug: Rituximab
    • Drug: Cytarabine
    • Drug: Thiotepa
    • Drug: Carmustin
  • Experimental: B
    Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
    • Drug: Rituximab
    • Drug: Cytarabine
    • Drug: Thiotepa
    • Drug: Carmustin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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