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Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy


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

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Trial Information

Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy


Inclusion Criteria:



- first diagnosis of PCNSL, histologically confirmed

- age > 65 years

- 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

- uncontrolled infection

- neutrophil count < 1.500/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)

- known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab,
leukovorin, or dexamethasone

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete remission rate

Outcome Time Frame:

30 days after end of immuno-chemotherapy

Safety Issue:

No

Principal Investigator

Gerald Illerhaus, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

00591

NCT ID:

NCT00989352

Start Date:

September 2009

Completion Date:

September 2011

Related Keywords:

  • Primary Non Hodgkin Lymphoma of the Central Nervous System
  • PCNSL
  • Lymphoma
  • Methotrexate
  • Lomustine
  • Procarbazine
  • Rituximab
  • Elderly
  • Chemotherapy
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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