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

Not Applicable

Terminated

Conditions: Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Chronic Phase Chronic Myelogenous Leukemia
de Novo Myelodysplastic Syndromes
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma

Interventions: Drug: plerixafor
Biological: filgrastim
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation

Registration Number: NCT01076270

Lead Sponsor: Fred Hutchinson Cancer Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Filgrastim and plerixafor for PBSC mobilization	plerixafor	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.
Filgrastim and plerixafor for PBSC mobilization	filgrastim	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.
Filgrastim and plerixafor for PBSC mobilization	peripheral blood stem cell transplantation	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.
Filgrastim and plerixafor for PBSC mobilization	allogeneic hematopoietic stem cell transplantation	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.

Primary Outcome Measures

Name	Time	Method
Successful Collection of Stem Cells	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

Secondary Outcome Measures