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

Primary Purpose

Primary Non Hodgkin Lymphoma of the Central Nervous System

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Methotrexate

Lomustine

Procarbazine

Rituximab

About this trial

This is an interventional treatment trial for Primary Non Hodgkin Lymphoma of the Central Nervous System focused on measuring PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Complete remission rate

Secondary Outcome Measures

Duration of response

Overall survival time

Neuropsychological state (according to Mini-Mental State and IPCG testing)

(Serious) adverse events ([S]AEs)

Full Information

NCT ID

NCT00989352

First Posted

October 2, 2009

Last Updated

October 2, 2009

Sponsor

University Hospital Freiburg

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00989352

Brief Title

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

Acronym

PRIMAIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Freiburg

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Non Hodgkin Lymphoma of the Central Nervous System

Keywords

PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

3g/m² i.v. max. 9 times

Intervention Type

Drug

Intervention Name(s)

Lomustine

Intervention Description

110 mg/m² p.o., max. 3 times

Intervention Type

Drug

Intervention Name(s)

Procarbazine

Intervention Description

60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

375 mg/m² i.v., max. 10 times

Primary Outcome Measure Information:

Title

Complete remission rate

Time Frame

30 days after end of immuno-chemotherapy

Secondary Outcome Measure Information:

Title

Duration of response

Time Frame

within 5 years

Title

Overall survival time

Time Frame

within 5 years

Title

Neuropsychological state (according to Mini-Mental State and IPCG testing)

Time Frame

within 5 years

Title

(Serious) adverse events ([S]AEs)

Time Frame

within 30 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gerald Illerhaus, PD Dr.

Phone

+497612703785

Gerald.Illerhaus@uniklinik-freiburg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Elvira Burger

Phone

+497612707378

elvira.burger@uniklinik-freiburg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald Illerhaus, PD Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerald Illerhaus, PD Dr.

Phone

+497612703785

Gerald.Illerhaus@uniklinik-freiburg.de

First Name & Middle Initial & Last Name & Degree

Elvira Burger

Phone

+497612707378

elvira.burger@uniklinik-freiburg.de

First Name & Middle Initial & Last Name & Degree

Gerald Illerhaus, PD Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

18953065

Citation

Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.

Results Reference

background

PubMed Identifier

27843136

Citation

Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.

Results Reference

derived

Links:

URL

http://www.zns-lymphome.de

Description

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

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