NCT01319591

Brief Summary

The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

3.4 years

First QC Date

March 18, 2011

Last Update Submit

January 18, 2019

Conditions

CNS LymphomaCNS Involvement of Systemic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.

    Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI.

    1 year

Secondary Outcomes (1)

  • To further compare each formula in a different subset of patients.

    1 year

Study Arms (1)

CNS lymphoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital

You may qualify if:

  • Age \>/= 18 years
  • Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
  • Available timed urine collection within 1 week of HDMTX

You may not qualify if:

  • Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
  • Documented viral hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Audrea H Szabatura, PharmD, BCOP

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medication Safety Officer

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2014

Study Completion

September 1, 2017

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)