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NCT01076270 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2017-06-28

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Successful Collection of Stem Cells

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outcome · POSTED

CD34-positive Cells Collected

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
true
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: plerixafor
    2. Biological: filgrastim
    3. Procedure: peripheral blood stem cell transplantation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    label
    Filgrastim and plerixafor for PBSC mobilization
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Filgrastim and plerixafor for PBSC mobilization
    description
    Given SC
    name
    plerixafor
    other Names
    1. AMD 3100
    2. Mozobil
    type
    DRUG
  2. arm Group Labels
    1. Filgrastim and plerixafor for PBSC mobilization
    description
    Given SC
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Filgrastim and plerixafor for PBSC mobilization
    description
    Infusion of peripheral blood stem cells
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBPC transplantation
    2. PBSC transplantation
    3. peripheral blood progenitor cell transplantation
    4. transplantation, peripheral blood stem cell
    type
    PROCEDURE
  4. arm Group Labels
    1. Filgrastim and plerixafor for PBSC mobilization
    description
    Infusion of hematopoietic stem cells
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
    measure
    Successful Collection of Stem Cells
    time Frame
    At the end of apheresis for cell collection
secondary Outcomes
  1. description
    Number of CD34-positive cells collected per kg recipient body weight
    measure
    CD34-positive Cells Collected
    time Frame
    At the end of apheresis for cell collection
Full study description
brief Summary
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
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice