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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01070 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8003 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.
PRIMARY OBJECTIVES:
I. To obtain results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days.
SECONDARY OBJECTIVES:
I. To achieve a response (cytoreduction or at least partial response) greater that than expected for comparable refractory patient populations with other salvage regimens.
OUTLINE:
A patient receives a drug intervention based on the results of a high throughput sensitivity assay. This assay best matches a drug to the patient's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy, biological therapy) | Experimental | Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antitumor drug screening assay | Other | Undergo high throughput drug sensitivity assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML | Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Response, Defined by Criteria of Cheson et al. | Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction). Cheson et al. defines a CR as: Bone Marrow blasts <5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 10^9/L, and platelet count >100 x 10^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (<1.0 x 10^9/L) or thrombocytopenia (<100 x 10^9/L). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Becker | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Chemotherapy, Biological Therapy) | Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. antitumor drug screening assay: Undergo high throughput drug sensitivity assay chemotherapy: Patients receive 1 of 160 possible interventions biological therapy: Patients receive 1 of 160 possible interventions 16 patients were enrolled. 14 patients were treated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| chemotherapy | Drug | Patients receive 1 of 160 possible interventions |
|
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| biological therapy | Biological | Patients receive 1 of 160 possible interventions |
|
| Baseline up to 2 years |
| COMPLETED |
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| NOT COMPLETED |
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relapsed, refractory AML patients. 16 patients were enrolled, 14 patients were treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Chemotherapy, Biological Therapy) | Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. antitumor drug screening assay: Undergo high throughput drug sensitivity assay chemotherapy: Patients receive 1 of 160 possible interventions biological therapy: Patients receive 1 of 160 possible interventions |
| 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 | No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML | Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results. | 14 patients were treated. | Posted | Median | Full Range | days | Up to 21 days |
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| |||||||||||||||||||||||||
| Secondary | Rate of Complete Response, Defined by Criteria of Cheson et al. | Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction). Cheson et al. defines a CR as: Bone Marrow blasts <5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 10^9/L, and platelet count >100 x 10^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (<1.0 x 10^9/L) or thrombocytopenia (<100 x 10^9/L). | 14 patients received therapy. Out of 14 patients treated, 9 were evaluable (4 patients died prior to D14-21 marrow and 1 patient refused the D14-21 marrow). | Posted | Number | Patients | Baseline up to 2 years |
|
|
2 years
Other [Not Including Serious] Adverse Events were not monitored/assessed.
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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 (Chemotherapy, Biological Therapy) | Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. antitumor drug screening assay: Undergo high throughput drug sensitivity assay chemotherapy: Patients receive 1 of 160 possible interventions biological therapy: Patients receive 1 of 160 possible interventions | 11 | 14 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seizure | Nervous system disorders | Systematic Assessment | due to thrombocytopenia due to underlying disease |
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| pneumonia | Infections and infestations | Systematic Assessment | fungal |
| |
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment | secondary to blast crisis |
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| malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| febrile neutropenia | Infections and infestations | Systematic Assessment |
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| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hypokalemia | Investigations | Systematic Assessment | intermittent |
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| confusion | Psychiatric disorders | Systematic Assessment | intermittent |
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| hyperbilirubinemia | Investigations | Systematic Assessment |
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| Hypoalbuminemia | Investigations | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment | stenotrophomonas maltophilia |
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| febrile neutropenia | Infections and infestations | Systematic Assessment | intermittent |
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| drug rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment | intermittent |
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| mucositis | Gastrointestinal disorders | Systematic Assessment |
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| hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| blood bilirubin increased | Investigations | Systematic Assessment |
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| bacteremia-GPC | Infections and infestations | Systematic Assessment |
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| sepsis | Infections and infestations | Systematic Assessment | Neutropenic secondary to GNR bacteremia |
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| hypotension | Vascular disorders | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | intermittent |
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| tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| pleural effusions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| worsening abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| severe bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| c-diff colitis infection | Infections and infestations | Systematic Assessment |
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| LE edema | General disorders | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | related to pleural effusion |
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| coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Elevated AST | Investigations | Systematic Assessment |
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| DIC | Blood and lymphatic system disorders | Systematic Assessment |
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| uric acid | Metabolism and nutrition disorders | Systematic Assessment |
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| acute systolic heart failure | Cardiac disorders | Systematic Assessment |
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| cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| refractory hypotension | Vascular disorders | Systematic Assessment |
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| refractory shock | General disorders | Systematic Assessment |
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| systolic dysfunction | Cardiac disorders | Systematic Assessment |
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| cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| multiorgan failure | General disorders | Systematic Assessment |
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| sepsis | Infections and infestations | Systematic Assessment |
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| Lung infection - pulmonary aspergillosis | Infections and infestations | Systematic Assessment |
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| skin infection - R leg cellulitis w/ abscess | Infections and infestations | Systematic Assessment |
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| Lung infection - Stenotrophomonas bacteremia | Infections and infestations | Systematic Assessment |
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| primary stenotrophomonas secondary AML | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Becker | University of Washington | 206-288-7273 | pbecker@u.washington.edu |
| 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 |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009196 | Myeloproliferative Disorders |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| 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 |
| D001855 | Bone Marrow Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
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| ID | Term |
|---|---|
| D004354 | Drug Screening Assays, Antitumor |
| D004358 | Drug Therapy |
| D001691 | Biological Therapy |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004353 | Drug Evaluation, Preclinical |
| D005069 | Evaluation Studies as Topic |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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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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