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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Primary Non Hodgkin Lymphoma of the Central Nervous System

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate

Outcome Time Frame:

30 days after blood stem cell transplantation

Safety Issue:

No

Principal Investigator

Jürgen Finke, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Ethics Commission

Study ID:

ZNS-00465

NCT ID:

NCT00647049

Start Date:

January 2007

Completion Date:

August 2013

Related Keywords:

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

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