A Phase 2 interventional study of Filgrastim and Plerixafor in Blood And Marrow Transplantation, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed.
Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body.
The safety and effectiveness of this drug combination will also be studied.
Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.
Stem Cell Transplant:
You will receive blood stem cells from a donor on this study. You will sign a separate informed consent for the transplant procedure.
Follow-Up Visits:
About 1, 3, and 6 months after the transplant, an extra sample of bone marrow (about 2 teaspoons) will be collected at the same time as the standard of care bone marrow aspiration/biopsy procedures. This bone marrow sample will be tested to find out how well the donated stem cells have been accepted by your body. However, you will not have a separate bone marrow aspiration/biopsy only to collect bone marrow for this testing.
When you return to the clinic at 6, 9, and 12 months for routine transplant follow-up visits, the study staff will try to get information on your health status from the clinic notes in your medical record. If this is not possible, you may receive a phone call from the study staff to check your health status. These calls will last about 10 minutes.
Length of Treatment:
You will be on study for about 1 year after the transplant (including follow-up contact by phone, if needed).
You may be taken off study early if you are not able to follow study directions or if you decide to leave the study.
This is an investigational study. Filgrastim is FDA approved for use in stem cell collection. Plerixafor is FDA approved for use in patients with multiple myeloma and non-Hodgkin's lymphoma.
Up to 30 donor and recipient pairs will take part in this study. All will be enrolled at MD Anderson.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each donor receives Filgrastim 5 µg/kg subcutaneously in the morning daily for 4 days. The dose of Filgrastim based on the donor's actual body weight. Donors will continue Filgrastim until completion of apheresis. Each donor receives Plerixafor 240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization. The dose-volume of Plerixafor based on the donor's actual body weight. Apheresis procedure to start the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor. The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor. The apheresis procedure may continue beyond day 1 until the target dose of 4x106 cluster of differentiation 34 (CD34+) cells/kg (recipient's weight) is obtained.
Drug: Filgrastim · Drug: Plerixafor · Procedure: Apheresis Procedure
5 µg/kg in the morning daily for 4 days.
Also known as: Neupogen, Granulocyte-colony stimulating factor, G-CSF, GCSF, CSF-3
240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.
Also known as: Mobozil
The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor. The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained.
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)
Primary safety endpoint is the development of any unexpected toxicity (any grade 2 or higher non-hematologic toxicity) in donors. The severity of the toxicity - adverse events (AEs) graded according to Common Terminology Criteria v4.0 (CTCAE).
Time frame: 5 days
Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor
Study determined to be feasible if all donors were able to receive Plerixafor without developing any grade 2 or higher non-hematologic toxicity. Feasibility of the combination of Filgrastim, Granulocyte-colony stimulating factor (G-CSF) plus Plerixafor is to effectively mobilize CD34+ cells so that an adequate transplant (\>4 x 10\^6 CD34+ cells/kg) can be reliably collected with one apheresis for allogeneic HSCT.
Time frame: 4 days
Recruitment Period: October 16, 2013 to May 1, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
| Milestone | Filgrastim + Plerixafor for Donors | Recipients |
|---|---|---|
| Started | 11 | 11 |
| Completed | 7 | 5 |
| Not completed | 4 | 6 |
| Withdrew: Not eligible due to white blood counts | 4 | 4 |
| Withdrew: Death | 0 | 2 |
Primary safety endpoint is the development of any unexpected toxicity (any grade 2 or higher non-hematologic toxicity) in donors. The severity of the toxicity - adverse events (AEs) graded according to Common Terminology Criteria v4.0 (CTCAE).
| adverse events | Donors: Filgrastim + Plerixafor |
|---|---|
| Tachycardia | 1 |
| Nausea | 2 |
| Insomnia | 2 |
| Bone pain | 2 |
| Injection site reaction | 1 |
| Diarrhea | 1 |
| Chest Pain | 1 |
Study determined to be feasible if all donors were able to receive Plerixafor without developing any grade 2 or higher non-hematologic toxicity. Feasibility of the combination of Filgrastim, Granulocyte-colony stimulating factor (G-CSF) plus Plerixafor is to effectively mobilize CD34+ cells so that an adequate transplant (\>4 x 10\^6 CD34+ cells/kg) can be reliably collected with one apheresis for allogeneic HSCT.
| Participants | Donors: Filgrastim + Plerixafor |
|---|---|
| Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor | 7 |
Collected over Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Donors Filgrastim + Plerixafor | — | 0/11 (0%) | 5/11 (45.5%) |
| Recipients | — | 0/11 (0%) | 7/11 (63.6%) |
| Event | Donors Filgrastim + Plerixafor | Recipients |
|---|---|---|
| NauseaGastrointestinal disorders | 2/11 | 7/11 |
| Mucositis oralGastrointestinal disorders | 0/11 | 5/11 |
| DiarrheaGastrointestinal disorders | 1/11 | 3/11 |
| Flu like symptomsGeneral disorders | 0/11 | 3/11 |
| PainGeneral disorders | 2/11 | 3/11 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 0/11 | 3/11 |
| Alanine aminotransferase increasedInvestigations | 0/11 | 2/11 |
| Bone painMusculoskeletal and connective tissue disorders | 2/11 | 0/11 |
| Creatinine increasedInvestigations | 0/11 | 2/11 |
| Elevated bilirubinHepatobiliary disorders | 0/11 | 2/11 |
| Age, Continuous(years) | Donors Filgrastim + Plerixafor | Recipients | Total |
|---|---|---|---|
| Median | 58 (37 to 74) | 58 (41 to 71) | 58 (37 to 74) |
| Sex: Female, Male(Participants) | Donors Filgrastim + Plerixafor | Recipients | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 4 | 6 | 10 |
| Race (NIH/OMB)(Participants) | Donors Filgrastim + Plerixafor | Recipients | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 8 | 8 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Donors Filgrastim + Plerixafor | Recipients | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center