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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01307 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
PRIMARY OBJECTIVES:
I. To determine if a one-year disease free survival of >= 35% can be achieved among patients >= 55 years old with de novo and secondary AML in first complete remission (CR1) who undergo nonmyeloablative hematopoietic stem cell transplant (HSCT) from human leukocyte antigen (HLA) identical related donors.
II. To determine if a day +200 nonrelapse related mortality of < 15% can be achieved among patients >= 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative HSCT from HLA identical related donors.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0.
TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) orally (PO) twice daily (BID) on days -3 to 56 with taper to day 77. Patients also receive mycophenolate mofetil (MMF) PO BID on days 0-27.
After completion of study treatment, patients are followed up on days 28, 56, and 84; months 6, 12, 18, and 24; and then yearly for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (nonmyeloablative donor PBSC transplant) | Experimental | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients receive CSP PO BID on days -3 to 56 with taper to day 77. Patients also receive MMF PO BID on days 0-27. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | Undergo nonmyeloablative allogeneic PBSC transplant |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival-incidence of Survival Without Relapse | Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%. | By 1 year after transplant |
| Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death | Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%. | 200 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Percent patients surviving. | By 1 year after transplant |
| Incidence of Relapse | Percent patients with relapsed disease post-transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda Sandmaier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Cancer Institute | Portland | Oregon | 97210 | United States | ||
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32499241 | Derived | Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Nonmyeloablative Donor PBSC Transplant) | Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27. Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant Fludarabine phosphate: Given IV Total-body irradiation: Undergo total-body irradiation Cyclosporine: Given PO Mycophenolate mofetil: Given PO Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| fludarabine phosphate | Drug | Given IV |
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| total-body irradiation | Radiation | Undergo TBI |
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| cyclosporine | Drug | Given PO |
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| mycophenolate mofetil | Drug | Given PO |
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| peripheral blood stem cell transplantation | Procedure | Undergo nonmyeloablative allogeneic PBSC transplant |
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| By 1 year after transplant |
| Incidence of Rejection | Percent patients who developed infections post-transplant. | By 1 year after transplant |
| Incidence of Acute and Chronic GVHD | Percent patients with acute/chronic GVHD | aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant. |
| Seattle |
| Washington |
| 98109 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Nonmyeloablative Donor PBSC Transplant) | Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27. Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant Fludarabine phosphate: Given IV Total-body irradiation: Undergo total-body irradiation Cyclosporine: Given PO Mycophenolate mofetil: Given PO Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Disease-free Survival-incidence of Survival Without Relapse | Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%. | Posted | Number | percentage of participants | By 1 year after transplant |
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| Primary | Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death | Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%. | Posted | Number | percentage of participants | 200 days after transplant |
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| Secondary | Overall Survival | Percent patients surviving. | Posted | Number | percentage of participants | By 1 year after transplant |
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| Secondary | Incidence of Relapse | Percent patients with relapsed disease post-transplant. | Posted | Number | percentage of participants | By 1 year after transplant |
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| Secondary | Incidence of Rejection | Percent patients who developed infections post-transplant. | Posted | Number | percentage of participants | By 1 year after transplant |
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| Secondary | Incidence of Acute and Chronic GVHD | Percent patients with acute/chronic GVHD | Posted | Number | percentage of participants | aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant. |
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AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
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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 | Treatment (Nonmyeloablative Donor PBSC Transplant) | Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27. Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant Fludarabine phosphate: Given IV Total-body irradiation: Undergo total-body irradiation Cyclosporine: Given PO Mycophenolate mofetil: Given PO Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant | 5 | 17 | 4 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GVHD | Immune system disorders | Systematic Assessment |
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| Secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenda M. Sandmaier | Fred Hutchinson Cancer Research Center | 206-667-4961 | bsandmai@fhcrc.org |
| ID | Term |
|---|---|
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D014916 | Whole-Body Irradiation |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| 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 |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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