Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

June 26, 2017 updated by: Fred Hutchinson Cancer Center

A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors

RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. The percentage of normal donors who collect at least 2 x 10^6 CD34 cells/kg recipient weight on day 1 after administration of combined filgrastim and plerixafor.

SECONDARY OBJECTIVES:

I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post dosing.

II. Tolerance and safety of combined filgrastim and Plerixafor in normal donors.

III. Engraftment of filgrastim/plerixafor mobilized stem cells in allogeneic recipients.

IV. Acute and chronic graft-versus-host disease (GVHD) following the use of filgrastim/plerixafor mobilized stem cells.

V. Yield of CD34+ cells based on donor weight.

OUTLINE: Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.

After completion of study treatment, donors are followed up 1 day after the last stem cell donation.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hematologic malignancy considered eligible and suitable for allogeneic stem cell transplantation (syngeneic transplantation is acceptable); diagnoses include acute myeloid or lymphoid leukemias, chronic myeloid or lymphoid leukemias, multiple myeloma, lymphoma or myelodysplasia; subjects suitable for this study will primarily receive transplant on a standard treatment plan (non research regimen)
  • Organ function, performance status and age suitable for an ablative regimen consisting of TBI >= 10Gy or a chemotherapy regimen consisting of busulphan and cyclophosphamide (BuCY) or busulphan and melphalan (BuMel)
  • Availability of a fully matched sibling donor
  • Ability to understand and willingness to sign an informed consent
  • No uncontrolled infections
  • DONOR: Human leukocyte antigen (HLA) identical sibling donor
  • DONOR: >= 18 years
  • DONOR: No unacceptable risk to donor due to pre-existing illness
  • DONOR: Must have suitable antecubital veins for leukapheresis venipuncture; donors who will require a temporary, Mahurkar-type catheter are not eligible
  • DONOR: Ability and willingness to sign an informed consent document

Exclusion Criteria:

  • Eligible for and willingness to participate in any research study of transplant regimens
  • Eligible for and willingness to participate in a non ablative transplant regimen
  • Human immunodeficiency virus (HIV) seropositive
  • Pregnancy
  • DONOR: HIV seropositive
  • DONOR: Contraindication or hypersensitivity to filgrastim or plerixafor
  • DONOR: Hepatitis A, B, C seropositive
  • DONOR: Pregnant or lactating females
  • DONOR: Liver function studies > 2 times the upper limit of normal (ULN) at evaluation, Creatinine > 2, pulmonary function diffusing lung capacity for carbon monoxide (DLCO) < 50% (if specifically evaluated), cardiac ejection fraction < 50% (if specifically evaluated)
  • DONOR: Any known ventricular arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Filgrastim and plerixafor for PBSC mobilization

Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.

After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Drug: plerixafor
Given SC
Other Names:
  • Mozobil
  • AMD 3100
Procedure: peripheral blood stem cell transplantation
Infusion of peripheral blood stem cells
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell
Procedure: allogeneic hematopoietic stem cell transplantation
Infusion of hematopoietic stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Collection of Stem Cells
Time Frame: At the end of apheresis for cell collection
Percentage of donors from whom at least 2 x 10^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
At the end of apheresis for cell collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD34-positive Cells Collected
Time Frame: At the end of apheresis for cell collection
Number of CD34-positive cells collected per kg recipient body weight
At the end of apheresis for cell collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (ESTIMATE)

February 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2385.00
  • NCI-2010-00252 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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