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Freiburg ZNS-NHL Study

Primary Purpose

Primary Non Hodgkin Lymphoma of the Central Nervous System

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
methotrexate
Rituximab
Cytarabine
Thiotepa
Carmustin
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Non Hodgkin Lymphoma of the Central Nervous System

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital FreiburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

first diagnosis of PCNSL: combined chemotherapy with methotrexate

Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

Duration of response
Overall survival time
Neuropsychological state according to Mini-Mental State
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)
(Serious) adverse events ([S]AEs)

Full Information

First Posted
March 26, 2008
Last Updated
November 16, 2009
Sponsor
University Hospital Freiburg
Collaborators
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00647049
Brief Title
Freiburg ZNS-NHL Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg
Collaborators
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Non Hodgkin Lymphoma of the Central Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
first diagnosis of PCNSL: combined chemotherapy with methotrexate
Arm Title
B
Arm Type
Experimental
Arm Description
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
MTX
Intervention Description
8000mg/m2 i.v., max. 2 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375mg/m2, max. 8 times
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Arabinoside
Intervention Description
3000mg/m2 die i.v., 2 days (max. 2 cycles)
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Description
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
Intervention Type
Drug
Intervention Name(s)
Carmustin
Other Intervention Name(s)
BCNU, Bis-Chlorethyl-Nitrosourea
Intervention Description
400mg/m2 i.v. for 1 day
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
30 days after blood stem cell transplantation
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
within 5 years
Title
Overall survival time
Time Frame
within 5 years
Title
Neuropsychological state according to Mini-Mental State
Time Frame
within 5 years
Title
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
Title
(Serious) adverse events ([S]AEs)
Time Frame
within 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Illerhaus, Dr.
Phone
00497612703785
Email
Gerald.Illerhaus@uniklinik-freiburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Zähringer, Dr.
Phone
00497612707370
Email
andreas.zaehringer@uniklinik-freiburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Finke, Prof. Dr.
Organizational Affiliation
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Illerhaus, Dr.
Phone
00497612703785
Email
Gerald.Illerhaus@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Andreas Zähringer
Phone
00497612707378
Email
andreas.zaehringer@uniklinik-freiburg.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
16864853
Citation
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. doi: 10.1200/JCO.2006.06.2117. Epub 2006 Jul 24.
Results Reference
background
PubMed Identifier
28559537
Citation
Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Roth A, Bloehdorn J, Mohle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31.
Results Reference
derived
PubMed Identifier
27476790
Citation
Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, Wolf HH, Hirt C, Stilgenbauer S, Binder M, Hau P, Edinger M, Frickhofen N, Bentz M, Mohle R, Roth A, Pfreundschuh M, von Baumgarten L, Deckert M, Hader C, Fricker H, Valk E, Schorb E, Fritsch K, Finke J. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016 Aug;3(8):e388-97. doi: 10.1016/S2352-3026(16)30050-3. Epub 2016 Jul 13.
Results Reference
derived

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Freiburg ZNS-NHL Study

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