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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02209 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Proteonomix, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgrastim + Plerixafor | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Drug | 5 µg/kg in the morning daily for 4 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
1) Donors who are on anti-coagulation or anti-platelet agents are not eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Chitra M. Hosing, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: October 16, 2013 to May 1, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filgrastim + Plerixafor for Donors | Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10^6 CD34+ cells/kg (recipient's weight) obtained. |
| FG001 | Recipients | Recipients received Plerixafor mobilized cells for allogeneic hematopoietic stem cell transplantation (HSCT) on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donors Filgrastim + Plerixafor | Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10^6 CD34+ cells/kg (recipient's weight) obtained. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | adverse events | 5 days |
|
|
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.
For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donors Filgrastim + Plerixafor | Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x106 CD34+ cells/kg (recipient's weight) obtained. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chitra Hosing, MD/Professor, Stem Cell Transplantation | UT MD Anderson Cancer Center | 713-792-7734 | cmhosing@mdanderson.org |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C088327 | plerixafor |
| D001781 | Blood Component Removal |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Plerixafor | Drug | 240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization. |
|
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| Apheresis Procedure | Procedure | 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. |
|
| Recipients |
Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Four participants did not receive Plerixafor due to a white blood cell count outside of the protocol specific window. It should be noted, the protocol threshold for white blood cell count was amended from 40,000 to 45,000. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | Recipients | Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan). | 0 | 11 | 7 | 11 |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mild tachicardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nightsweats | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Elevated bilirubin | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutropenic fever | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| CMV Reactivation, Alpha-hemalytic streptococcus bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Injection site reaction | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Altered mental status related to pain medication | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fluid Overload | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hand & foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Catheter related deep vein thrombosis (DTV) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D013812 | Therapeutics |