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Trial Title:
Freiburg ZNS-NHL Study
NCT ID:
NCT00647049
Condition:
Primary Non Hodgkin Lymphoma of the Central Nervous System
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Cytarabine
Rituximab
Methotrexate
Thiotepa
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
methotrexate
Description:
8000mg/m2 i.v., max. 2 cycles
Arm group label:
A
Other name:
MTX
Intervention type:
Drug
Intervention name:
Rituximab
Description:
375mg/m2, max. 8 times
Arm group label:
A
Arm group label:
B
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Arm group label:
A
Arm group label:
B
Other name:
Arabinoside
Intervention type:
Drug
Intervention name:
Thiotepa
Description:
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Arm group label:
A
Arm group label:
B
Intervention type:
Drug
Intervention name:
Carmustin
Description:
400mg/m2 i.v. for 1 day
Arm group label:
A
Arm group label:
B
Other name:
BCNU
Other name:
Bis-Chlorethyl-Nitrosourea
Summary:
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].
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Gerald Illerhaus, Dr.
Phone:
00497612703785
Email:
Gerald.Illerhaus@uniklinik-freiburg.de
Contact backup:
Last name:
Andreas Zähringer
Phone:
00497612707378
Email:
andreas.zaehringer@uniklinik-freiburg.de
Start date:
January 2007
Completion date:
August 2013
Lead sponsor:
Agency:
University Hospital Freiburg
Agency class:
Other
Collaborator:
Agency:
University Hospital Tuebingen
Agency class:
Other
Source:
University Hospital Freiburg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00647049
