Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma (PRIMAIN)

October 2, 2009 updated by: University Hospital Freiburg

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

The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete remission rate
Time Frame: 30 days after end of immuno-chemotherapy
30 days after end of immuno-chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: within 5 years
within 5 years
Overall survival time
Time Frame: within 5 years
within 5 years
Neuropsychological state (according to Mini-Mental State and IPCG testing)
Time Frame: within 5 years
within 5 years
(Serious) adverse events ([S]AEs)
Time Frame: within 30 days after treatment
within 30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Collaborators

Ludwig-Maximilians - University of Munich
University Hospital Heidelberg
University Hospital Ulm
Universitätsklinikum Köln

Investigators

  • Principal Investigator: Gerald Illerhaus, PD Dr., University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00591
  • Eudract: 2008-007645-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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