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| ID | Type | Description | Link |
|---|---|---|---|
| 97843 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| BMT190 | Other Identifier | OnCore |
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Poor accrual
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allo-HSCT + TLI + ATG | Experimental | Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
|
|
| Best Standard Care | Active Comparator | Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic HSCT | Procedure | Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Robert Lowsky | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Hayward | California | 94545 | United States | ||
| Cedars-Sinai Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allo-HSCT + TLI + ATG | Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg. Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV Cyclosporine (CSP): 6.25 mg/kg twice daily oral Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions. Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Treatment assignment was based on availability of an HLA-matched donor.
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|
| Anti-thymocyte globulin (ATG) | Drug | 1.5 mg/kg for 5 days by IV |
|
|
| Cyclosporine (CSP) | Drug | 6.25 mg/kg twice daily oral |
|
|
| Mycophenolate mofetil (MMF) | Drug | 15 mg/kg twice daily oral |
|
|
| Total lymphoid irradiation (TLI) | Radiation | 80 cGy/fraction radiotherapy in 10 fractions. |
|
| Methylprednisolone sodium succinate | Drug | 1.0 mg/kg for 5 days by IV |
|
|
| Best standard care | Drug | Intervention consist of:
|
|
|
| 2 years |
| Non-relapse Mortality | Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). | 2 years |
| Relapse Rate | Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). | 2 years |
| Transplant-related Mortality | Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion). | 100 days and 6 months |
| Complete Donor Hematopoietic Cell Chimerism | Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. | 2 years |
| Early Graft Loss | Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. | 2 years |
| Patients Completing the Intended Therapy in Both Arms | The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion | 2 years |
| Los Angeles |
| California |
| 90048 |
| United States |
| Univeristy of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| FG001 | Best Standard Care | Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
Best standard care: Intervention consist of:
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allo-HSCT + TLI + ATG | Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg. Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV Cyclosporine (CSP): 6.25 mg/kg twice daily oral Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions. Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV |
| BG001 | Best Standard Care | Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
Best standard care: Intervention consist of:
|
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Overall Survival (OS) | Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). | Posted | Count of Participants | Participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Non-relapse Mortality | Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Relapse Rate | Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Transplant-related Mortality | Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion). | Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes. | Posted | Count of Participants | Participants | 100 days and 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Complete Donor Hematopoietic Cell Chimerism | Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. | Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes. | Posted | Number | percentage of participants | 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Early Graft Loss | Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. | Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes. | Posted | Number | percentage of participants | 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Patients Completing the Intended Therapy in Both Arms | The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion | Posted | Number | percentage of participants | 2 years |
|
2 years
Non-serious adverse events were not collected in this study.
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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 | Allo-HSCT + TLI + ATG | Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg. Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV Cyclosporine (CSP): 6.25 mg/kg twice daily oral Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions. Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV | 16 | 25 | 20 | 25 | 0 | 25 |
| EG001 | Best Standard Care | Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
Best standard care: Intervention consist of:
| 20 | 33 | 24 | 33 | 0 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse, leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Death not otherwise specified | General disorders | Non-systematic Assessment |
| ||
| Altered mental status | Nervous system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Lowsky, Professor of Medicine (Blood and Marrow Transplantation) | Stanford University | 650-725-8950 | rlowsky@stanford.edu |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D018380 | Hematopoietic Stem Cell Transplantation |
| D014180 | Transplantation |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D008776 | Methylprednisolone Hemisuccinate |
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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|
|
|
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Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
Best standard care: Intervention consist of:
|
|
|
Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:
Best standard care: Intervention consist of:
|
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|
|
|
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