Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
| Verified date | June 2017 |
| Source | Fred Hutchinson Cancer Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | February 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful Collection of Stem Cells | 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 | CD34-positive Cells Collected | Number of CD34-positive cells collected per kg recipient body weight | At the end of apheresis for cell collection |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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