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Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

NCT01339572 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-08-01

No results posted yet for this study

Summary

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Conditions

Interventions

DRUG

Plerixafor

240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5. 2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.

DRUG

Filgrastim

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Jack W Hsu, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01339572 on ClinicalTrials.gov