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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation.
Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational.
Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML.
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.
Approximately one third of patients with AML have a particular change in their leukemia cells (called a mutation) in a gene called FLT3. The presence of a FLT3 mutation can be used to direct treatment options.
This is an open-label phase II study. Patients will receive standard chemotherapy of daunorubicin and cytarabine during Induction and high-dose cytarabine during Consolidation. Patients will be randomized to gilteritinib or midostaurin. After approximately 90 patient's complete treatment, a review of the effectiveness of gliteritinib compared to midostaurin will be done. If gilteritinib is not as effective as midostaurin, the study may be stopped.
Bone marrow aspirate and biopsy will be done on Day 21 after start of Induction and after Induction to assess response. Patients with a complete response may proceed to consolidation chemotherapy. Another bone marrow aspirate and biopsy will be done after the first cycle of consolidation is complete.
Mandatory prescreening bone marrow and/or blood samples are required for FLT3 testing. Any left-over samples will be requested for future research (optional).
Mandatory bone marrow samples for research are required after Induction and if patient receives Consolidation, after the first cycle of Consolidation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. |
|
| Arm B | Active Comparator | Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gilteritinib | Drug | Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | FLT3 mutation negative (evaluated by polymerase chain reaction [PCR]) Composite Complete Response (CRc) [includes CR and CRi] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | CR evaluated by FLT3 testing after Induction | 3 months |
| Minimal Residual Disease (MRD)- CRc Rate at End of Induction | MRD- CRc evaluated by flow cytometry after Induction |
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Registration Criteria:
Randomization Eligibility Criteria:
Patient must have previously untreated FLT3 mutated Non M3 AML (FLT3-TKD or FLT3-ITD allowed).
° Standard of care induction 7+3 chemotherapy may start prior to randomization using same regimen and doses as defined in the protocol while awaiting prescreening test results.
Patient must have had no prior systemic therapy for AML, except as noted below:
Patient may not have received hypomethylating agent within 21 days.
Patient may not have M3 AML.
Patient may not have AML with known Core Binding Factor -t(8;21), inv(16), t(16;16).
Patient may not have known active Central Nervous System (CNS) leukemia.
° Prophylaxis with intrathecal chemotherapy is allowed prior to or during induction/consolidation.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Patient must be age ≥ 18 years to ≤ 70 years.
Patient must be able to understand and willing to sign Institutional Review Board (IRB)-approved informed consent.
Patient must be willing to provide mandatory bone marrow and blood samples for research.
Patient must have adequate organ function as measured by the following criteria, obtained ≤ 48 hours prior to randomization except ECG and left ventricular ejection fraction (LVEF) which can be done ≤ 2 weeks prior to randomization:
The patient may not be known to have hypokalemia and/or hypomagnesemia that does not respond to supplementation.
A female patient is eligible to participate if she is not pregnant and at least one of the following conditions apply:
Female patient must agree not to breastfeed or donate ova starting at treatment and throughout the study period, and for at least 180 days after the final study drug administration.
A male patient must agree not to donate sperm starting at treatment and throughout the study period, and for at least 120 days after the final study drug administration.
A male patient with female partner(s) of child-bearing potential must agree to use contraception during the treatment period, and for at least 120 days after the final study drug administration.
Male patient with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the treatment period, and for at least 120 days after the final study drug administration.
Patient may not have another malignancy that could interfere with the evaluation of safety or efficacy of this combination.
Patient may not have a history of Long QT Syndrome.
Patient may not have evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or congestive heart failure (CHF) New York Heart Association (NYHA) Class 3 or 4. Patient may also not have a history of CHF NYHA Class 3 or 4 in the past, unless a prescreening echocardiogram (ECHO) or multigated acquisition scan (MUGA) performed within 2 weeks prior to study entry with results of left ventricular ejection fraction >45%.
Patient may not have had major surgery or radiation therapy within 4 weeks of registration.
Patient may not require treatment with concomitant drugs that are strong inducers of CYP3A and P-gp.
Patient with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
Patient with known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of gilteritinib or midostaurin including difficulty swallowing are not eligible.
Patient with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.
Patient may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.
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| Name | Affiliation | Role |
|---|---|---|
| Selena Luger, MD | University of Pennsylvania | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California, San Francisco-Fresno (University Oncology Associates) |
Data is proprietary.
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All randomized, eligible, and treated patients.
3 patients passed away/withdrew before induction. 1 patient determined to not have the diagnosis to meet the eligibility criteria and was removed from the study (181 consented).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles |
| 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 | Yes | No | No | Study Protocol | Oct 5, 2022 | Sep 12, 2024 |
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Open-Label, Randomized trial of Daunorubicin/Cytarabine and High Dose Cytarabine + Gilteritinib vs Midostaurin for Induction and Consolidation. FLT3 mutated patients will be stratified based on TKD vs ITD. Patients who are FLT3 ITD will be further stratified by Signal Ratio (high vs. low of FLT3 Wild Type) and Nucleophosmin 1-Mutated (NPM1) [positive vs negative].
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|
| Midostaurin | Drug | Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) |
|
|
| Daunorubicin | Drug | First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 |
|
|
| Cytarabine | Drug | Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles |
|
|
| 3 months |
| CRc (CR or CRi) Rate at End of Induction | CRc assessed in accordance with 2017 European LeukemiaNet (ELN) | 3 months |
| Event Free Survival (EFS) | EFS assessed in accordance with 2017 ELN | 68 months |
| Overall Survival (OS) | OS assessed in accordance with 2017 ELN | 68 months |
| Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Number of participants with abnormal laboratory values and/or adverse events | 10 months |
| Clovis |
| California |
| 93611 |
| United States |
| UCLA | Los Angeles | California | 90095 | United States |
| Kaiser Permanente Oakland | Oakland | California | 94611 | United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| Kaiser Permanente Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente Santa Clara | Santa Clara | California | 94115 | United States |
| Mayo Clinic- Jacksonville, FL | Jacksonville | Florida | 32224 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60451 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | United States |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| St. Joseph's Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic- Rochester, MN | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Atlantic Health Systems/Morristown Medical Center | Morristown | New Jersey | 07962 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Medicine New York Presbyterian Hospital | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| MultiCare | Spokane | Washington | 99218 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | United States |
| Marshfield Medical Center | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| FG001 | Arm B | Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles |
| BG001 | Arm B | Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles |
| 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, 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 |
| ||||||||||||||||
| ECOG (Eastern Cooperative Oncology Group) Performance Score | 0: Fully active, able to carry on all pre-disease performance without restriction.
| Count of Participants | Participants |
| |||||||||||||||
| AML Category | De Novo AML: AML that develops spontaneously without prior blood disorders or cancer treatments. Often associated with a comparatively better prognosis Therapy-Related AML (t-AML): AML that arises as a result of previous chemotherapy or radiation therapy. Generally considered a higher-risk category AML with Myelodysplasia-Related Changes (AML-MRC): AML that originates from or shows features of prior myelodysplastic syndromes or dysplasia. Also associated with a worse prognosis compared to De Novo AML | Count of Participants | Participants |
| |||||||||||||||
| WHO Classification | Count of Participants | 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 | FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction | FLT3 mutation negative (evaluated by polymerase chain reaction [PCR]) Composite Complete Response (CRc) [includes CR and CRi] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction | CR evaluated by FLT3 testing after Induction | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Minimal Residual Disease (MRD)- CRc Rate at End of Induction | MRD- CRc evaluated by flow cytometry after Induction | Posted | Count of Participants | Participants | 3 months |
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| Secondary | CRc (CR or CRi) Rate at End of Induction | CRc assessed in accordance with 2017 European LeukemiaNet (ELN) | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | EFS assessed in accordance with 2017 ELN | Not Posted | 68 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS assessed in accordance with 2017 ELN | Not Posted | 68 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Treatment-related Adverse Events as Assessed by CTCAE v5.0 | Number of participants with abnormal laboratory values and/or adverse events | Posted | Count of Participants | Participants | 10 months |
|
Adverse events (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.
A serious adverse event (SAE) is any untoward medical occurrence after study treatment initiation that results in death, is life-threatening, requires or prolongs hospitalization, causes disability/incapacity, is a congenital anomaly, or, based on medical judgment, may jeopardize the patient or require intervention to prevent serious outcomes.
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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 | Arm A | Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles | 23 | 90 | 48 | 90 | 83 | 90 |
| EG001 | Arm B | Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles | 27 | 87 | 39 | 87 | 81 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Stomatitis haemorrhagic | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Cranial nerve disorder | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypotension | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | CTCAE V 5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | CTCAE V 5.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE V 5.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE V 5.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE V 5.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li Chen, MS; Statistician | PrECOG | 857-284-3670 | Li Chen <lic@ds.dfci.harvard.edu> |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2023 | Sep 12, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609080 | gilteritinib |
| C059539 | midostaurin |
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| 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 |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Unknown |
|
| De Novo AML |
|
| Therapy-Related AML |
|
| AML with certain genetic abnormalities |
|
| AML with myelodysplasia-related changes |
|
| AML not otherwise specified |
|
|
|
|
|
|
|
|
|
|
|
|