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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00006772 | Other Identifier | University of Michigan Medical School |
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The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fludarabine plus Busulfan (CR) | Experimental | Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2). |
|
| Fludarabine plus Busulfan (PR) | Experimental | Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Fludarabine (40 mg/m2/day x 4 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Relapse Free Survival at 1 Year | The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive at 1 Year | One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor. | 1 year |
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Inclusion Criteria:
For Study Registration:
For Proceeding to Transplant:
Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
Exclusion Criteria:
For Study Registration:
For Proceeding to Transplant:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Yanik, MD | University of Michigan Comprehesive Cancer Ctr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fludarabine Plus Busulfan | Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days) Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant. Patients will undergo an allogeneic stem cell transplant from related or unrelated donor. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fludarabine Plus Busulfan | Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days) Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant. Patients will undergo an allogeneic stem cell transplant from related or unrelated donor. |
| 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 | Percentage of Participants With Relapse Free Survival at 1 Year | The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen. | 56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft). | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
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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 | Fludarabine Plus Busulfan | Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days) Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant. Patients will undergo an allogeneic stem cell transplant from related or unrelated donor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Yanik, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-8785 | gyanik@umich.edu |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| D014916 | Whole-Body Irradiation |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Busulfan | Drug | Busulfan (3.2 mg/m2/day x 2 days or x 4 days). |
|
| Total Body Irradiation | Radiation | Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant. |
|
| Stem Cell Transplant | Procedure | Allogeneic stem cell transplant from related or unrelated donor |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants Alive at 1 Year | One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor. | 56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft). | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| 21 |
| 56 |
| 16 |
| 56 |
| Hypotension | Cardiac disorders |
|
| Fever | General disorders |
|
| Death not associated with CTCAE term | General disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Hematoma | Vascular disorders |
|
| Febrile neutropenia | Infections and infestations |
|
| Blood Infection | Infections and infestations |
|
| Soft Tissue Infection | Infections and infestations |
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| Infection - Other | Infections and infestations |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders |
|
| Confusion | Nervous system disorders |
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| Dizziness | Nervous system disorders |
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| Mental status | Psychiatric disorders |
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| Seizure | Nervous system disorders |
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| Syncope (fainting) | Nervous system disorders |
|
| Abdomen Pain | Gastrointestinal disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
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| Chest Wall Pain | Musculoskeletal and connective tissue disorders |
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| Chest/Thorax Pain | Cardiac disorders |
|
| Syndromes - Other | General disorders |
|
| Thrombosis/embolism (vascular access-related) | Vascular disorders |
|
| Thrombosis/thrombus/embolism | Vascular disorders |
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| Mucositis/stomatitis | Gastrointestinal disorders |
|
| Infection | Infections and infestations |
|
| Blood Infection | Infections and infestations |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Thrombosis (vascular access related) | Vascular disorders |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |