Freiburg ZNS-NHL Study

Primary Non Hodgkin Lymphoma of the Central Nervous System Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00647049
• Other study ID #: ZNS-00465
• Status: Recruiting
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: November 16, 2009
• Start date: January 2007
• Est. completion date: August 2013

Study information

• Verified date: November 2009
• Source: University Hospital Freiburg
• Contact: Gerald Illerhaus, Dr.
• Phone: 00497612703785
• Email: Gerald.Illerhaus[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Primary Non Hodgkin Lymphoma of the Central Nervous System

Intervention

Drug:
• methotrexate
8000mg/m2 i.v., max. 2 cycles
• Rituximab
375mg/m2, max. 8 times
• Cytarabine
3000mg/m2 die i.v., 2 days (max. 2 cycles)
• Thiotepa
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
• Carmustin
400mg/m2 i.v. for 1 day

Locations

Country	Name	City	State
Germany	University Hospital Freiburg	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		30 days after blood stem cell transplantation	No
Secondary	Duration of response		within 5 years	No
Secondary	Overall survival time		within 5 years	No
Secondary	Neuropsychological state according to Mini-Mental State		within 5 years	Yes
Secondary	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	Yes
Secondary	(Serious) adverse events ([S]AEs)		within 30 days after treatment	Yes