Study Stopped
Funding withdrawal
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
A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
2 other identifiers
interventional
1
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedJune 28, 2017
June 1, 2017
7 months
February 24, 2010
February 15, 2017
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
CD34-positive Cells Collected
At the end of apheresis for cell collection
Study Arms (1)
Filgrastim and plerixafor for PBSC mobilization
EXPERIMENTALDonors 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.
Interventions
Given SC
Given SC
Infusion of peripheral blood stem cells
Infusion of hematopoietic stem cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only one patient was enrolled in this trial.
Results Point of Contact
- Title
- Dr. William Bensinger
- Organization
- Fred Hutchinson Cancer Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
William Bensinger
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2010
First Posted
February 26, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
June 28, 2017
Results First Posted
March 31, 2017
Record last verified: 2017-06