NCT01916577

Brief Summary

The purpose of this study is to determine if the drug Plerixafor (Mozobil) can lead to clinically relevant efflux of CD117+ stem cells from the bone marrow to the peripheral blood of normal controls and patients awaiting lung transplantation. The investigator's hypothesis is that Plerixafor (Mozobil) will lead to significant mobilization of CD117+ stem cells to the peripheral blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1

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

First Submitted

Initial submission to the registry

July 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

4.2 years

First QC Date

July 29, 2013

Last Update Submit

February 6, 2018

Conditions

COPDCystic FibrosisPulmonary Fibrosis

Keywords

Stem Cell MobilizationStem CellsTransplantationAutologous

Outcome Measures

Primary Outcomes (1)

  • The number of circulating CD117+ cells per milliliter (ml) of peripheral blood at baseline and following Plerixafor (Mozobil) treatment (change in peripheral blood CD117+ cells per ml).

    At baseline and at 8 hours post-Plerixafor (Mozobil) treatment

Secondary Outcomes (4)

  • The number of Plerixafor (Mozobil) related adverse events (AEs)

    For 30 minutes after administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment.

  • The number of patients with Plerixafor (Mozobil) related adverse events

    For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment

  • The number of Plerixafor (Mozobil) related serious adverse events (SAEs).

    For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment

  • The number of patients with Plerixafor (Mozobil) related serious adverse events (SAEs)

    For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment

Study Arms (2)

Plerixafor (Mozobil) Control Arm

ACTIVE COMPARATOR

Plerixafor mobilization of autologous CD117 stem cells: Plerixafor will be given at 240mcg/kg subcutaneously once to 5 normal control patients (volunteers) at time zero with blood collected for flow cytometric analysis for CD117+ peripheral blood cells prior to the dose and then again 8 hours after the dose

Drug: Plerixafor mobilization of autologous CD117 stem cells

Plerixafor (Mozobil) Experimental Arm

EXPERIMENTAL

Plerixafor mobilization of autologous CD117 stem cells: Plerixafor will be given at 240mcg/kg subcutaneously once to 5 COPD, 5 Cystic Fibrosis, and 5 Pulmonary Fibrosis patients (awaiting lung transplantation) at time zero with blood collected for flow cytometric analysis for CD117+ peripheral blood cells just prior to the dose and then again 8 hours after the dose

Drug: Plerixafor mobilization of autologous CD117 stem cells

Interventions

Plerixafor mobilization of autologous CD117 stem cellsDRUG

Peripheral mobilization of autologous CD117+ stem cells from the bone marrow in patients awaiting lung transplantation versus normal controls

Also known as: Mozobil
Plerixafor (Mozobil) Control ArmPlerixafor (Mozobil) Experimental Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on the Univ. of Colorado Lung Transplant Waiting List Age 18 to 70 years old Ability to sign and understand informed consent
  • Patients 18 years or older up to age 70 on the University of Colorado Lung Transplant Waiting List and normal control subjects will be eligible for enrollment. Patients will include those with Chronic Obstructive Lung Disease, Pulmonary Fibrosis and Cystic Fibrosis
  • Normal control subjects = 5
  • Lung Transplant waitlist patients = 15 (5 each with COPD, PF or CF to determine whether disease affects mobilization potential)

You may not qualify if:

  • Subject has already undergone lung transplantation.
  • Subject has a known or suspected allergy to Plerixafor.
  • Women of child-bearing age who are unwilling to use appropriate birth control to prevent becoming pregnant.
  • Subjects who have received an investigational agent or device within 30 days of administration of the study agent. For the purposes of this trial, an investigational agent or device is any which is implemented under an Investigational New Drug Application (IND).
  • Subjects with a history of Hepatitis B or C.
  • Subjects with significant anemia (HCT \< 35),thrombocytopenia (Plt count \<100,000/cc), leukocytosis (WBC \> 12,000/cc), or leucopenia (WBC \< 5,000/cc).
  • Subjects with splenomegaly.
  • Subjects unable to comply with all protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Blum A, Childs RW, Smith A, Patibandla S, Zalos G, Samsel L, McCoy JP, Calandra G, Csako G, Cannon RO 3rd. Targeted antagonism of CXCR4 mobilizes progenitor cells under investigation for cardiovascular disease. Cytotherapy. 2009;11(8):1016-9. doi: 10.3109/14653240903131640.

    PMID: 19929465BACKGROUND

  • Bonig H, Chudziak D, Priestley G, Papayannopoulou T. Insights into the biology of mobilized hematopoietic stem/progenitor cells through innovative treatment schedules of the CXCR4 antagonist AMD3100. Exp Hematol. 2009 Mar;37(3):402-15.e1. doi: 10.1016/j.exphem.2008.10.017. Epub 2009 Jan 20.

    PMID: 19157683BACKGROUND

  • D'Addio A, Curti A, Worel N, Douglas K, Motta MR, Rizzi S, Dan E, Taioli S, Giudice V, Agis H, Kopetzky G, Soutar R, Casadei B, Baccarani M, Lemoli RM. The addition of plerixafor is safe and allows adequate PBSC collection in multiple myeloma and lymphoma patients poor mobilizers after chemotherapy and G-CSF. Bone Marrow Transplant. 2011 Mar;46(3):356-63. doi: 10.1038/bmt.2010.128. Epub 2010 May 31.

    PMID: 20577218BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCystic FibrosisPulmonary Fibrosis

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesLung Diseases, InterstitialFibrosis

Study Officials

  • Todd Grazia, M.D.

    The University of Colorado Denver - Anschutz Medical Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(1)