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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03827 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2545.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| R01HL108307 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.
PRIMARY OBJECTIVES:
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.
SECONDARY OBJECTIVES:
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.
OUTLINE:
Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (donor statin treatment) | Experimental | Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo myeloablative allogeneic PBSC transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 Acute GVHD | Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients. | First 100 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Extensive GVHD | Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients. | 2 years post transplant |
| Disease-free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Mielcarek | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States | ||
| Colorado Blood Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Donors | Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant Atorvastatin Calcium: Given PO Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Atorvastatin Calcium | Drug | Given PO |
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| Peripheral Blood Stem Cell Transplantation | Procedure | Undergo myeloablative allogeneic PBSC transplant |
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Evaluated as Kaplan-Meier estimate in the patients/recipients.
| 1 year after transplant |
| Grades II-IV Acute GVHD | Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients. | First 100 days after transplant |
| Non-relapse Mortality | Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients. | At day 100 |
| Non-relapse Mortality | Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients. | At 1 year after HCT |
| Overall Survival | Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients. | 1 year after transplant |
| Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity | Until completion of stem cell collection (on average 14 days) |
| Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy | First 100 days after transplant |
| Recurrent or Progressive Malignancy | Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients. | Up to 3 years |
| Denver |
| Colorado |
| 80907 |
| United States |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| FG001 |
| Patients |
Recipients of donor stem cells. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Donors | Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant Atorvastatin Calcium: Given PO Peripheral Blood Stem Cell Transplantation: Undergo myeloablative allogeneic PBSC transplant |
| BG001 | Patients | Recipients of donor stem cells. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Grade 3-4 Acute GVHD | Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | First 100 days after transplant |
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| Secondary | Chronic Extensive GVHD | Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | 2 years post transplant |
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| Secondary | Disease-free Survival | Evaluated as Kaplan-Meier estimate in the patients/recipients. | Posted | Number | 95% Confidence Interval | disease free survival probability | 1 year after transplant |
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| Secondary | Grades II-IV Acute GVHD | Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | First 100 days after transplant |
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| Secondary | Non-relapse Mortality | Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | At day 100 |
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| Secondary | Non-relapse Mortality | Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | At 1 year after HCT |
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| Secondary | Overall Survival | Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients. | Posted | Number | 95% Confidence Interval | survival probability | 1 year after transplant |
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| Secondary | Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity | Posted | Count of Participants | Participants | Until completion of stem cell collection (on average 14 days) |
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| Secondary | Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy | Posted | Count of Participants | Participants | First 100 days after transplant |
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| Secondary | Recurrent or Progressive Malignancy | Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients. | Posted | Number | 95% Confidence Interval | probability | Up to 3 years |
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Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier. Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.
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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 | Patient Adverse Events | Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier. | 21 | 38 | 0 | 38 | ||
| EG001 | Donor Adverse Events | Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier. | 0 | 41 | 0 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DAH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Multi-Organ Failure | General disorders | Non-systematic Assessment |
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| Fever/Infection | Infections and infestations | Non-systematic Assessment |
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| Metabolic Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Pneumotosis | Gastrointestinal disorders | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
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| Pulmonary Emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| GVHD | Immune system disorders | Non-systematic Assessment |
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| Relapse | Blood and lymphatic system disorders | Non-systematic Assessment |
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| IPS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
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| ARDS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Dehydration | Vascular disorders | Non-systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| EBV-PTLD | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marco Mielcarek | Fred Hutchinson Cancer Research Center | 2066672827 | mmielcar@fredhutch.org |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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