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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01299 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9226 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG1015012 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the feasibility of choosing treatment based on a high throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients with acute leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). A high throughput screening assay tests many different drugs individually or in combination that kill leukemia cells in tiny chambers at the same time. High throughput drug sensitivity assay and mutation analysis may help guide the choice most effective for an individual's acute leukemia.
PRIMARY OBJECTIVES:
I. To test patient cells in a high throughput assay against individual drugs and drug combinations within 21 days to enable optimal choice of drug combinations for therapy.
II. To test gene expression that reveals activation of druggable pathways or mutations in genes that confer susceptibility to specific agents may also be considered in choice of treatment.
SECONDARY OBJECTIVE:
I. To evaluate the response to the chosen therapy.
OUTLINE:
Leukemia cells obtained from blood or bone marrow are analyzed for sensitivity to both individual drugs and drug combinations via high throughput chemotherapy sensitivity assay and next generation sequencing assays. Doctors will then recommend chemotherapy regimens based on the results.
After completion of the chemotherapy regimen, patients are followed up at 2-4 weeks for response, and then every 3 months for 2 years for duration of response and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemosensitivity testing, chemotherapy) | Experimental | Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemosensitivity Assay | Other | Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients we Are Able to Test and Initiate Treatment Within a 21 Day Period | The study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a combination drug regimen within 21 days in 9 out of 15 patients. With that outcome, there would be 90% confidence that the true feasibility rate is at least 40%. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Remission | The secondary objective is to evaluate the response to the chosen therapy. Response will be evaluated using European LeukemiaNet Response Evaluation Criteria in AML (2010 version) | Up to 2 years |
| Survival |
Not provided
Inclusion Criteria:
Diagnosis of acute leukemia by World Health Organization (WHO) criteria (e.g.-acute myeloid leukemia, acute lymphoblastic leukemia, acute leukemia of ambiguous origin)
Either:
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
Expectation that we can obtain about 10 million blasts from blood and/or marrow (e.g., circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts)
Bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SPGT) (alanine aminotransferase [ALT]) =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
Alkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
Serum creatinine =< 2.0 mg/dL
Informed consent
Willing to use contraception when appropriate
Expected survival is greater than 100 days
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Elizabeth Percival | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemosensitivity Testing | Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing. Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs: Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2020 |
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|
| Cytology Specimen Collection Procedure | Other | Undergo blood or bone marrow collection |
|
|
| Gene Expression Analysis | Genetic | Analysis of leukemia cell genes to identify possible drug targets |
|
| Genetic Variation Analysis | Genetic | Analysis of leukemia cell genes to identify possible drug targets |
|
|
| In Vitro Sensitivity-Directed Chemotherapy | Drug | Receive personalized chemotherapy with one or more of the following drugs: Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin |
|
Disease free and overall survival data will be assessed by contacting the referring MD or the patient every three months for the first two years.
| Up to 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemosensitivity Testing | Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing. Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs: Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin |
| 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 | Full Range | 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 | Percentage of Patients we Are Able to Test and Initiate Treatment Within a 21 Day Period | The study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a combination drug regimen within 21 days in 9 out of 15 patients. With that outcome, there would be 90% confidence that the true feasibility rate is at least 40%. | Posted | Count of Participants | Participants | Up to 21 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Complete Remission | The secondary objective is to evaluate the response to the chosen therapy. Response will be evaluated using European LeukemiaNet Response Evaluation Criteria in AML (2010 version) | Number of complete remissions + complete remissions with incomplete blood counts | Posted | Count of Participants | Participants | Up to 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Survival | Disease free and overall survival data will be assessed by contacting the referring MD or the patient every three months for the first two years. | Overall survival in months from date of study consent | Posted | Mean | Standard Deviation | months | Up to 2 years |
|
5 years
Non-hematologic toxicities >/= grade 3 were recorded from time of assay-guided therapy administration through 14 days after last administration of study therapy Hospitalizations or prolongation of hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e. awaiting transport home) were not considered SAEs. And hospitalization or prolongation of hospitalizations for fever and/or infection were considered expected, and not considered SAEs.
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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 | Chemosensitivity Testing | Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing. Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs: Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin | 32 | 34 | 11 | 34 | 26 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Enterobacter Cloacae Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoxemic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenic fever with Sepsis Physiology | Infections and infestations | Non-systematic Assessment |
| ||
| Intermittent Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhizopus Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Non-systematic Assessment |
| ||
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation with RVR | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Anorectal Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Bacteremia Infection | Infections and infestations | Non-systematic Assessment |
| ||
| C. Diff Colitis with Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Catheter Related Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Central Line Associated DVT | Vascular disorders | Non-systematic Assessment |
| ||
| Coag Negative Staph Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Distributive Shock | Infections and infestations | Non-systematic Assessment |
| ||
| Enterocolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Eye Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Febrile Neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| Granulicatella Adiacens Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Hyperbilirubinemia | Investigations | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| INR Increased | Investigations | Non-systematic Assessment |
| ||
| Invasive Fungal Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Oral Mucositis | Infections and infestations | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pseudomonas Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rash Maculopapular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rothia Mucilaginosa Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Staph Epidermidis Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcus Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Stenotrophomonas Maltophilia Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| Subdural Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Transaminitis | Investigations | Non-systematic Assessment |
| ||
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Percival | University Of Washington | 206-606-1320 | mperciva@seattlecca.org |
| May 27, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015456 | Leukemia, Biphenotypic, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D014644 | Genetic Variation |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D055614 | Genetic Phenomena |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|