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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

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