NCT00914849

Brief Summary

To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

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

June 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

August 24, 2016

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

June 1, 2009

Results QC Date

July 14, 2016

Last Update Submit

April 6, 2017

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant

    Completion of enrollment of all donors (17 months)

Secondary Outcomes (13)

  • Number of Donors Who Experience Grade 3-4 Infusional Toxicity

    Up to Day 2

  • Number of Recipients Who Have Neutrophil Engraftment

    Day 21

  • Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)

    Day 1 and Day 2

  • Pharmacokinetics of IV AMD3100 as Measured by Half Life

    Day 1 and Day 2

  • Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)

    Day 1 and Day 2

  • +8 more secondary outcomes

Study Arms (2)

Arm 1 - Donor

EXPERIMENTAL

* Day 1 * AMD3100 320 ug/kg IV * Leukopheresis * Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient) * AMD3100 320 ug/kg IV * Leukopheresis

Drug: AMD3100Procedure: Leukopheresis

Arm 2 - Recipient

EXPERIMENTAL

Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM Day 0 = Stem Cell Transplant

Procedure: Stem cell transplant

Interventions

AMD3100DRUG
Also known as: Mozobil, Plerixafor
Arm 1 - Donor
LeukopheresisPROCEDURE
Arm 1 - Donor
Stem cell transplantPROCEDURE
Arm 2 - Recipient

Eligibility Criteria

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

You may qualify if:

  • Donor Eligibility
  • Donor is 18 to 70 years of age inclusive.
  • If female and of child-bearing age: must be non-pregnant, not breast feeding and agree to use adequate contraception.
  • Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
  • Donor must be willing to provide written informed consent.
  • Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
  • Adequate renal function as defined by a calculated serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
  • Adequate hepatic function as defined by a total bilirubin \<2x normal or absence of hepatic fibrosis/cirrhosis.
  • Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
  • Donor must be HIV-1\&2 antibody and HTLV-I\&II antibody sero-negative, by Food and Drug Administration (FDA) licensed test.
  • Donor must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Donor must demonstrate ability to be compliant with study regimen.
  • Donor must not have an active infection at the time of study entry.
  • Donor does not have active alcohol or substance abuse within 6 months of study entry.
  • Donor is not currently enrolled on another investigational agent study.
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (10)

  • Levesque JP, Hendy J, Takamatsu Y, Simmons PJ, Bendall LJ. Disruption of the CXCR4/CXCL12 chemotactic interaction during hematopoietic stem cell mobilization induced by GCSF or cyclophosphamide. J Clin Invest. 2003 Jan;111(2):187-96. doi: 10.1172/JCI15994.

    PMID: 12531874BACKGROUND

  • Peled A, Petit I, Kollet O, Magid M, Ponomaryov T, Byk T, Nagler A, Ben-Hur H, Many A, Shultz L, Lider O, Alon R, Zipori D, Lapidot T. Dependence of human stem cell engraftment and repopulation of NOD/SCID mice on CXCR4. Science. 1999 Feb 5;283(5403):845-8. doi: 10.1126/science.283.5403.845.

    PMID: 9933168BACKGROUND

  • Broxmeyer HE, Hangoc G, Cooper S, Bridger G. Interference of the SDF-1/CXCR4 axis in mice with AMD3100 induces rapid high level mobilization of hematopoietic progenitor cells, and AMD3100 acts synergistically with G-CSF and MIP-1 alpha to mobilize progenitors. Blood. 2001;96:3371a

    BACKGROUND

  • Broxmeyer HE, Hangoc G, Cooper S, Li X, Bridger G, Clapp DW. AMD3100, an antagonist of CXCR4 and mobilizer of myeloid progenitor cells, is a potent mobilizer of competitive repopulating long term marrow self renewing stem cells in mice. Blood. 2002;98:2397a

    BACKGROUND

  • Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15;102(8):2728-30. doi: 10.1182/blood-2003-02-0663. Epub 2003 Jul 10.

    PMID: 12855591BACKGROUND

  • Devine S, Adkins D, Khoury H, Vij R, Goodnough LT, Graubert T, Tomasson M, Blum W, DiPersio J, Brown R. Mobilization of donors with GM-CSF plus G-CSF or GM-CSF alone results in significantly different graft composition compared to G-CSF alone. Blood. 2002;100:825a

    BACKGROUND

  • Devine SM, Vij R, Rettig M, Todt L, McGlauchlen K, Fisher N, Devine H, Link DC, Calandra G, Bridger G, Westervelt P, Dipersio JF. Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction. Blood. 2008 Aug 15;112(4):990-8. doi: 10.1182/blood-2007-12-130179. Epub 2008 Apr 21.

    PMID: 18426988BACKGROUND

  • Broxmeyer HE, Orschell CM, Clapp DW, Hangoc G, Cooper S, Plett PA, Liles WC, Li X, Graham-Evans B, Campbell TB, Calandra G, Bridger G, Dale DC, Srour EF. Rapid mobilization of murine and human hematopoietic stem and progenitor cells with AMD3100, a CXCR4 antagonist. J Exp Med. 2005 Apr 18;201(8):1307-18. doi: 10.1084/jem.20041385.

    PMID: 15837815BACKGROUND

  • Hess DA, Bonde J, Craft TP, Wirthlin L, Hohm S, Lahey R, Todt LM, Dipersio JF, Devine SM, Nolta JA. Human progenitor cells rapidly mobilized by AMD3100 repopulate NOD/SCID mice with increased frequency in comparison to cells from the same donor mobilized by granulocyte colony stimulating factor. Biol Blood Marrow Transplant. 2007 Apr;13(4):398-411. doi: 10.1016/j.bbmt.2006.12.445.

    PMID: 17382247BACKGROUND

  • Schroeder MA, Rettig MP, Lopez S, Christ S, Fiala M, Eades W, Mir FA, Shao J, McFarland K, Trinkaus K, Shannon W, Deych E, Yu J, Vij R, Stockerl-Goldstein K, Cashen AF, Uy GL, Abboud CN, Westervelt P, DiPersio JF. Mobilization of allogeneic peripheral blood stem cell donors with intravenous plerixafor mobilizes a unique graft. Blood. 2017 May 11;129(19):2680-2692. doi: 10.1182/blood-2016-09-739722. Epub 2017 Mar 14.

    PMID: 28292947DERIVED

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

plerixaforLeukapheresisStem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesCell TransplantationCell- and Tissue-Based TherapyTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
John DiPersio, M.D., Ph.D.
Organization
Washington University School of Medicine
jdipersi@dom.wustl.edu
314-454-8304

Study Officials

  • John DiPersio, M.D., Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 5, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2012

Last Updated

May 17, 2017

Results First Posted

August 24, 2016

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)