NCT00647049

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 \[PCNSL\].

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

6.3 years

First QC Date

March 26, 2008

Last Update Submit

November 16, 2009

Conditions

Primary Non Hodgkin Lymphoma of the Central Nervous System

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    30 days after blood stem cell transplantation

Secondary Outcomes (5)

  • Duration of response

    within 5 years

  • Overall survival time

    within 5 years

  • Neuropsychological state according to Mini-Mental State

    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)

    within 5 years

  • (Serious) adverse events ([S]AEs)

    within 30 days after treatment

Study Arms (2)

A

EXPERIMENTAL

first diagnosis of PCNSL: combined chemotherapy with methotrexate

Drug: methotrexateDrug: RituximabDrug: CytarabineDrug: ThiotepaDrug: Carmustin

B

EXPERIMENTAL

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

Drug: RituximabDrug: CytarabineDrug: ThiotepaDrug: Carmustin

Interventions

methotrexateDRUG

8000mg/m2 i.v., max. 2 cycles

Also known as: MTX
A
RituximabDRUG

375mg/m2, max. 8 times

AB
CytarabineDRUG

3000mg/m2 die i.v., 2 days (max. 2 cycles)

Also known as: Arabinoside
AB
ThiotepaDRUG

40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days

AB
CarmustinDRUG

400mg/m2 i.v. for 1 day

Also known as: BCNU, Bis-Chlorethyl-Nitrosourea
AB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16864853BACKGROUND

  • 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.

    PMID: 28559537DERIVED

  • 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.

    PMID: 27476790DERIVED

MeSH Terms

Interventions

MethotrexateRituximabCytarabineThiotepaCarmustine

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesNitrosourea CompoundsUreaAmidesNitroso Compounds

Study Officials

  • Jürgen Finke, Prof. Dr.

    University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Illerhaus, Dr.

CONTACT

00497612703785Gerald.Illerhaus@uniklinik-freiburg.de

Andreas Zähringer, Dr.

CONTACT

00497612707370andreas.zaehringer@uniklinik-freiburg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

November 17, 2009

Record last verified: 2009-11

Locations

DE(1)