Nordic Study in Newly Diagnosed Primary Central Nervous S... | NCT01458730

Studies
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

NCT01458730

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Aug 4, 2022Actual

Enrollment

66Actual

Phase

Phase 2

Conditions

Central Nervous System Lymphoma

Interventions

Immunochemotherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Aug 2022Actual

First Submitted Date

Sep 15, 2011

First Submission Date that Met QC Criteria

Oct 24, 2011

First Posted Date

Oct 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2022

Last Update Posted Date

Aug 4, 2022Actual

Name	Class
Nordic Cancer Union	OTHER
Roche Pharma AG	INDUSTRY
Mundipharma Pte Ltd.	INDUSTRY
Schering-Plough

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.

Detailed Description

The objective of the study is

To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
To assess the long term outcome concerning neurotoxicity

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Name	Type	Description	Arm Group Labels	Other Names
Immunochemotherapy	Drug	Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte

Measure	Description	Time Frame
Overall survival

Measure	Description	Time Frame
response rate		at completion of therapy
neurotoxicity		1-10 years after completion of therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
Patients treated with steroids alone are eligible
No signs of lymphoma outside the CNS
ECOG performance status 0-4
Age > 17 and < 76 years
Written informed consent from the patient or guardian

Exclusion Criteria:

Cardiac failure > 3
Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
Previous malignancy unless disease free for at least five years
Active infection.
Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
Positive HIV status
Organ transplantation
Serious psychiatric illness
Prior radiotherapy to the brain
Concomitant anti-inflammatory medication that cannot be discontinued
Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Elisa Jacobsen Pulczynski		Aarhus		DK-8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25480497	Derived	Pulczynski EJ, Kuittinen O, Erlanson M, Hagberg H, Fossa A, Eriksson M, Nordstrom M, Ostenstad B, Fluge O, Leppa S, Fiirgaard B, Bersvendsen H, Fagerli UM. Successful change of treatment strategy in elderly patients with primary central nervous system lymphoma by de-escalating induction and introducing temozolomide maintenance: results from a phase II study by the Nordic Lymphoma Group. Haematologica. 2015 Apr;100(4):534-40. doi: 10.3324/haematol.2014.108472. Epub 2014 Dec 5.