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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001061-83 | EudraCT Number | ||
| BMT CTN 1506 | Other Identifier | Blood and Marrow Transplant Clinical Trials Network |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Blood and Marrow Transplant Clinical Trials Network | NETWORK |
Not provided
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The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergone allogeneic hematopoietic stem cell transplant (HCT) were randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants wiere stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gilteritinib | Experimental | Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met. |
|
| Placebo | Placebo Comparator | Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gilteritinib | Drug | oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival (RFS) | RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events:
| From the date of randomization up to 64 months and 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization until the date of death from any cause (death date - first dose date + 1). For a Participant who were not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1). | From the date of randomization up to 64 months and 22 day |
Not provided
Registration Inclusion Criteria
Participant is considered a suitable candidate for HCT and has an acceptable source of allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for any donor source [matched sibling, unrelated donor (URD), mismatched URD, related haploidentical, or umbilical cord blood] and any graft source [umbilical cord, BM, peripheral blood (PB)], and any conditioning [myeloablative conditioning (MAC), reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)] will be permitted).
Participant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).
Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib.
Participant has confirmed, morphologically documented AML in CR1. For the purposes of registration, CR1 will be defined as < 5% blasts in the BM with no morphologic characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
Participant has presence of the FLT3/ITD activating mutation in the BM or PB as determined by the local institution at diagnosis.
Participant must meet the following criteria as indicated on the clinical laboratory tests:
Participant has left ventricular ejection fraction at rest ≥ 40%.
Participant has diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) ≥ 50% predicted and/or forced expiratory volume in 1 second (FEV1) ≥ 50% predicted.
Female participants must either:
Or, if of childbearing potential,
Female participants must agree not to breastfeed or donate ova throughout the study drug treatment period and for 6 months after the final study drug administration.
Male participants (even if surgically sterilized), and partners who are women of childbearing potential must be using highly effective contraception in addition to a barrier method throughout the study drug treatment period and for 127 days after the final study drug administration.
Male participants must not donate sperm throughout the study drug treatment period and for 127 days after the final study drug administration.
Participant is able to take an oral medication.
Participant agrees not to participate in another interventional study while on treatment.
Randomization Inclusion Criteria
Participant is ≥ 30 days and ≤ 90 days from hematopoietic cell infusion.
Participant has achieved engraftment. Engraftment is defined as ANC ≥ 500 cells/μL and platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day apart). The participant must not have had a platelet transfusion within 7 days prior to the first measurement.
Participant has confirmed ongoing morphologically documented AML in CR1. For the purposes of randomization, CR1 will be defined as < 5% blasts with no morphologic characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
Participant meets the following criteria as indicated on the clinical laboratory tests:
If the participant has developed overall grades II-IV acute GVHD, the following criteria must be met to be randomized:
Participant is able to take oral medication.
Registration Exclusion Criteria
Participant has had a prior allogeneic transplant.
Participant has Karnofsky performance status score < 70% .
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of start of study drug.
Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.
Participant has a Fridericia-corrected QT interval (QTcF) > 450 msec (average of triplicate determinations) per central read.
Participant has long QT Syndrome at screening.
Participant has a known infection with human immunodeficiency virus (HIV).
Participant has active hepatitis B infection as determined by NAAT or surface antigen assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.
Participant has active hepatitis C infection as determined by NAAT. NAAT must be performed if the participant has positive serology for hepatitis C. Participants who have had past exposure and have no detectable virus either through spontaneous clearance or treatment are eligible.
Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to registration. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to registration.
Participant has had a myocardial infarction within 6 months prior to registration or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
Participant has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Participant is breast feeding or pregnant.
Participant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ.
Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.
Randomization Exclusion Criteria
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of starting study drug.
Participant requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered by the investigator to be absolutely essential for the care of the participant and for which no acceptable alternative exists.
Participant has a QTcF interval > 450 msec (average of triplicate determinations) by central read.
Participant has a need for supplemental oxygen with the exception of using previously existing non-invasive continuous positive airway pressure (CPAP) at night.
Participant has used investigational agents within 4 weeks of randomization.
Participant has used experimental therapy for acute GVHD within 4 weeks of randomization. If unsure of the definition of "experimental", discussion with one of the protocol chairs is recommended.
Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40590852 | Derived | Levis MJ, Hamadani M, Logan BR, Jones RJ, Singh AK, Litzow MR, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Oshima MU, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly LS, Kim HJ, Stelljes M, Najima Y, Onozawa M, Thomson K, Chen C, Hasabou N, Rosales M, Hill JE, Gill SC, Nuthethi R, King D, Mendizabal A, Devine SM, Horowitz MM, Chen YB. Impact of transplant conditioning, NPM1 mutations, and measurable residual disease in FLT3-ITD acute myeloid leukemia. Blood Adv. 2025 Oct 28;9(20):5123-5133. doi: 10.1182/bloodadvances.2025016306. | |
| 39775763 |
| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
Not provided
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Randomization was stratified by: Conditioning regimen intensity myeloablative vs reduced intensity/non-myeloablative (RIC/NMA); Time from first day of hematopoietic cell infusion to randomization (30 to 60 vs 61 to 90 days); Presence vs absence of/unknown, Minimal Residual Disease-4 (MRD-4) from the most recent pre-registration Bone marrow (BM).
Participants with FMS-like tyrosine kinase 3/Internal tandem duplication (FLT3/ITD) acute myeloid leukemia (AML) in first morphological complete remission (CR1) including complete remission with incomplete platelet recovery (CRp) & complete remission with incomplete hematologic recovery (CRi) undergoing allogeneic hematopoietic cell transplant (HCT) were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gilteritinib | Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Aug 19, 2022 | May 6, 2024 |
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| Drug |
oral |
|
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which did not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether considered related to the medicinal product. TEAE defined as an AE event observed through 30 days after the last dose. | From the date of randomization through 30 days after the last dose, up to 25 months and 22 days |
| Karnofsky Performance Status Scores | KPS scores of participants were reported. KPS was a standard way of measuring ability of cancer participants to perform ordinary tasks. It was 11 level score which ranged between 0-100%. 100 =Normal, no complaints, no evidence of disease 90 =Able to carry on normal activity, minor signs or symptoms of disease 80 =Normal activity with effort, some signs or symptoms of disease 70 =Care for self, unable to carry on normal activity or to do work 60 =Required occasional assistance but was able to care for most of his needs 50 =Required considerable assistance & frequent medical care 40 =Disabled, required special care & assistance 30 = Severely disabled, hospitalization indicated, although death not imminent 20 =Very sick, hospitalization necessary, active supportive treatment necessary 10 =moribund fatal processes progressing rapidly 0 =Dead. | Baseline, month 24 |
| Percentage of Participants With Non-relapse Mortality (NRM) | NRM was defined as death from any cause other than relapse or disease progression (DP). Relapse was defined as documentation of any of the following events:
| From the date of randomization up to 64 months and 22 days |
| Event-free Survival (EFS) | EFS: Time from date of randomization until documented relapse, or premature discontinuation of treatment or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first. Relapse was defined as documentation of any of following events:
Anti-leukemic treatment was defined as hypomethylating agents, chemotherapy, oral anticancer agents, Donor lymphocyte infusion (DLI) or cellular therapies given because of detectable disease, not meeting R-IWG criteria for relapse. | From the date of randomization up to 64 months and 22 days |
| Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD) | The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV aGVHD were reported, treating death prior to aGVHD as the competing risk. It was graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The acute GVHD algorithm calculated the grade based on the organ (skin, gastrointestinal (GI)and liver) stage and etiology/biopsy reported on the weekly GVHD form. Grade I aGVHD was defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD was stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV was stage 4 of skin, or stage 4 of liver. Grade IV was the worst outcome. Treatment emergent was defined as an event observed through 30 days after the last dose. | From the date of randomization up to 6 months |
| Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months | Chronic GVHD was graded according to diagnosis and severity scoring from the National Institute of Health (NIH) 2014 Consensus Criteria. Eight organs - skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia were scored on a 0-3 scale to reflect degree of chronic GVHD involvement, where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 12 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose. | From the date of randomization up to 12 months |
| Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months | Chronic GVHD was graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria. Eight organs- skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are scored on a 0-3 scale to reflect degree of chronic GVHD involvement where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 24 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose. | From the date of randomization up to 24 months |
| Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD) | The presence of MRD was considered Detectable in participants who were FLT3/ITD MRD undetectable prior to randomization if log10-transformed overall FLT3/ITD mutation ratio greater than -4 otherwise presence of MRD was considered Not Detectable. Participants who had detectable FLT3/ITD MRD prior to randomization were considered eradicated if log10-transformed overall FLT3/ITD mutation ratio ≤ -4. Incidence of MRD Eradication and Detection were estimated using the cumulative incidence function, treating death during MRD assessment period without documentation of MRD event as competing risk. | From the date of randomization up to 64 months and 22 days |
| Percentage of Participants With Relapse | Cumulative incidence of relapse was reported, treating death in remission as a competing risk. Relapse was defined as documentation of any of the following events:
| From the date of randomization up to 64 months and 22 days |
| Percentage of Participants With Treatment Emergent Infection by Severity. | Severity of Infection was assessed based on the following criteria: Grade 1-Mild Asymptomatic or mild symptoms, clinical or diagnostic observations noted intervention not indicated. Grade 2-Moderate Local or noninvasive intervention indicated. Grade 3-Severe Medically significant but not immediately life threatening, hospitalization or prolonged hospitalization. Grade 4-Life Threatening Life threatening consequences, urgent intervention indicated. Grade 5-Death related to the AE. Cumulative incidence of grade 3 to 5 infections were reported, treating death (grade 5) as a competing event. Treatment emergent was defined as an event observed through 30 days after the last dose. | From the date of randomization through 30 days after the last dose, up to 25 months and 22 days |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Virginia G Piper Cancer Center | Scottsdale | Arizona | 85258 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northside | Atlanta | Georgia | 30342 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana Blood and Marrow Transplant | Indianapolis | Indiana | 46237 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7233 | United States |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| University of Minnesota School of Medicine | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Memorial Sloan Kettering | New York | New York | 10065 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University, The | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84143 | United States |
| Intermountain BMT | Salt Lake City | Utah | 84143 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506-9214 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Site AU61001 | Liverpool | Australia |
| Site AU61002 | Melbourne | Australia |
| Site AU61004 | Westmead | Australia |
| Site BE32003 | Brussels | Belgium |
| Site BE32004 | Ghent | Belgium |
| Site CA15004 | Hamilton | Canada |
| Site CA15003 | Montreal | Canada |
| Site DK45002 | Aarhus | Denmark |
| Site DK45001 | Copenhagen | Denmark |
| Site FR33007 | Lille | France |
| Site FR33004 | Lyon | France |
| Site FR33005 | Paris | France |
| Site FR33008 | Pessac | France |
| Site FR33010 | Vandœuvre-lès-Nancy | France |
| Site DE49006 | Cologne | Germany |
| Site DE49002 | Düsseldorf | Germany |
| Site DE49003 | Halle | Germany |
| Site DE49005 | Hamburg | Germany |
| Site DE49007 | Mainz | Germany |
| Site DE49004 | Münster | Germany |
| Site GR30004 | Athens | Greece |
| Site GR30003 | Rio | Greece |
| Site GR30001 | Thessaloniki | Greece |
| Site IT39005 | Bergamo | Italy |
| Site IT39006 | Bologna | Italy |
| Site IT39009 | Genova | 16132 | Italy |
| Site IT39002 | Milan | Italy |
| Site IT39007 | Milan | Italy |
| Site IT39011 | Pescara | Italy |
| Site IT39003 | Roma | Italy |
| Site IT39004 | Udine | Italy |
| Site JP81014 | Anjo | Aichi-ken | Japan |
| Site JP81011 | Nagoya | Aichi-ken | Japan |
| Site JP81018 | Sapporo | Hokkaido | Japan |
| Site JP81021 | Kobe | Hyōgo | Japan |
| Site JP81012 | Nishinomiya | Hyōgo | Japan |
| Site JP81002 | Isehara | Kanagawa | Japan |
| Site JP81007 | Yokohama | Kanagawa | Japan |
| Site JP81010 | Sendai | Miyagi | Japan |
| Site JP81006 | Suita | Osaka | Japan |
| Site JP81008 | Shimotsuke | Tochigi | Japan |
| Site JP81013 | Bunkyo-ku | Tokyo | Japan |
| Site JP81004 | Chuo-ku | Tokyo | Japan |
| Site JP81016 | Minato-ku | Tokyo | Japan |
| Site JP81020 | Shinjuku-ku | Tokyo | Japan |
| Site JP81001 | Fukuoka | Japan |
| Site JP81003 | Fukuoka | Japan |
| Site JP81015 | Kyoto | Japan |
| Site JP81017 | Okayama | Japan |
| Site JP81005 | Osaka | Japan |
| Site NZ64002 | Christchurch | New Zealand |
| Site NZ64001 | Grafton | 1010 | New Zealand |
| Site PL48004 | Warsaw | Poland |
| Site KR82001 | Seoul | South Korea |
| Site KR82002 | Seoul | South Korea |
| Site KR82003 | Seoul | South Korea |
| Site KR82004 | Seoul | South Korea |
| Site KR82005 | Seoul | South Korea |
| Site ES34004 | Barcelona | 08036 | Spain |
| Site ES34005 | Barcelona | Spain |
| Site ES34006 | Salamanca | Spain |
| Site ES34007 | Santander | Spain |
| Site ES34002 | Valencia | Spain |
| Site TW88603 | Taichung | Taiwan |
| Site TW88602 | Taipei | Taiwan |
| Site TW88605 | Taoyuan | Taiwan |
| Site GB44010 | Birmingham | United Kingdom |
| Site GB44003 | Bristol | United Kingdom |
| Site GB44009 | Glasgow | G12 0YN | United Kingdom |
| Site GB44004 | London | United Kingdom |
| Site GB44002 | Manchester | United Kingdom |
| Site GB44001 | Sutton | United Kingdom |
| Derived |
| Levis MJ, Hamadani M, Logan BR, Jones RJ, Singh AK, Litzow MR, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Oshima MU, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly LS, Kim HJ, Stelljes M, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Chen C, Hasabou N, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Mendizabal A, Devine SM, Horowitz MM, Chen YB. Measurable residual disease and posttransplantation gilteritinib maintenance for patients with FLT3-ITD-mutated AML. Blood. 2025 May 8;145(19):2138-2148. doi: 10.1182/blood.2024025154. |
| 39167766 | Derived | Hamilton BK, Pandya BJ, Ivanescu C, Elsouda D, Hamadani M, Chen YB, Levis MJ, Ueda Oshima M, Litzow MR, Soiffer RJ, Ustun C, Perl AE, Singh AK, Geller N, Hasabou N, Rosales M, Cella D, Corredoira L, Pestana C, Horowitz MM, Logan B. Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+ acute myeloid leukemia. Blood Adv. 2024 Oct 8;8(19):5091-5099. doi: 10.1182/bloodadvances.2024013746. |
| 38663769 | Derived | Pandya BJ, Burns LJ, Wang T, Xie B, Touya M, Spalding J, Block A, Kuperman G, Young C. Clinical Outcomes and Treatment Patterns in Adults With FLT3-ITDmut+ Acute Myeloid Leukemia Undergoing Allogeneic Hemopoietic Cell Transplantation in the United States and Canada. Transplant Cell Ther. 2024 Jul;30(7):683.e1-683.e13. doi: 10.1016/j.jtct.2024.04.016. Epub 2024 Apr 23. |
| 38471061 | Derived | Levis MJ, Hamadani M, Logan B, Jones RJ, Singh AK, Litzow M, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Ueda Oshima M, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly L, Kim HJ, Mikesch JH, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Geller NL, Hasabou N, Delgado D, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Wittsack H, Mendizabal A, Devine SM, Horowitz MM, Chen YB; BMT-CTN 1506/MORPHO Study Investigators. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3. J Clin Oncol. 2024 May 20;42(15):1766-1775. doi: 10.1200/JCO.23.02474. Epub 2024 Mar 12. |
Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
| Safety Analysis Population |
|
| Intent to Treat (ITT) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-Treat (ITT) population: All randomized participants were included in this population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gilteritinib | Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met. |
| BG001 | Placebo | Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met. |
| 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 |
| ||||||||||||||||
| Number of participants with conditioning regimen intensity | Conditioning regimen intensity categorized by myeloablative conditioning (MAC) vs RIC/NMA were reported. MAC regimen consisted: Total body irradiation (TBI) ≥ 5 gray (Gy) single dose or ≥ 8 Gy fractionated/oral Busulfan > 8 milligrams per kilogram (mg/kg)/6.4 mg/kg intravenous (IV) (total dose)/treosulfan >30000 milligrams per square meter (mg/m^2)/elphalan >150 mg/m^2/thiotepa ≥10 mg/kg. RIC/NMA: Any regimen that did not meet MAC regimen: Interactive Response Technology (IRT) analysis was used. | Count of Participants | Participants |
| |||||||||||||||
| Number of Participants With Time from first day of hematopoietic cell infusion to randomization | Number of participants with time from first day of hematopoietic cell infusion to randomization categorized as 30 to 60 days vs 61 to 90 days were reported. | Count of Participants | Participants |
| |||||||||||||||
| Presence of MRD | Number of participants with presence versus absence of, or unknown, MRD-4 from the most recent pre-registration BM aspirate was reported. IRT analysis was used. The presence of MRD was considered "Detectable" if log10-transformed overall FLT3/ITD mutation ratio was greater than -4; otherwise, the presence of MRD was considered "Not Detectable. | 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 | Relapse-free Survival (RFS) | RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events:
| ITT population | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to 64 months and 22 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization until the date of death from any cause (death date - first dose date + 1). For a Participant who were not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1). | ITT population | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to 64 months and 22 day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which did not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether considered related to the medicinal product. TEAE defined as an AE event observed through 30 days after the last dose. | Safety Analysis Population: consisted of all participants who took at least 1 dose of study drug (gilteritinib or placebo). | Posted | Number | participants | From the date of randomization through 30 days after the last dose, up to 25 months and 22 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Karnofsky Performance Status Scores | KPS scores of participants were reported. KPS was a standard way of measuring ability of cancer participants to perform ordinary tasks. It was 11 level score which ranged between 0-100%. 100 =Normal, no complaints, no evidence of disease 90 =Able to carry on normal activity, minor signs or symptoms of disease 80 =Normal activity with effort, some signs or symptoms of disease 70 =Care for self, unable to carry on normal activity or to do work 60 =Required occasional assistance but was able to care for most of his needs 50 =Required considerable assistance & frequent medical care 40 =Disabled, required special care & assistance 30 = Severely disabled, hospitalization indicated, although death not imminent 20 =Very sick, hospitalization necessary, active supportive treatment necessary 10 =moribund fatal processes progressing rapidly 0 =Dead. | Safety Analysis Population with available data was analyzed. | Posted | Mean | Standard Deviation | unit on a scale | Baseline, month 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Non-relapse Mortality (NRM) | NRM was defined as death from any cause other than relapse or disease progression (DP). Relapse was defined as documentation of any of the following events:
| ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 64 months and 22 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | EFS: Time from date of randomization until documented relapse, or premature discontinuation of treatment or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first. Relapse was defined as documentation of any of following events:
Anti-leukemic treatment was defined as hypomethylating agents, chemotherapy, oral anticancer agents, Donor lymphocyte infusion (DLI) or cellular therapies given because of detectable disease, not meeting R-IWG criteria for relapse. | ITT population | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to 64 months and 22 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD) | The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV aGVHD were reported, treating death prior to aGVHD as the competing risk. It was graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The acute GVHD algorithm calculated the grade based on the organ (skin, gastrointestinal (GI)and liver) stage and etiology/biopsy reported on the weekly GVHD form. Grade I aGVHD was defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD was stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV was stage 4 of skin, or stage 4 of liver. Grade IV was the worst outcome. Treatment emergent was defined as an event observed through 30 days after the last dose. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months | Chronic GVHD was graded according to diagnosis and severity scoring from the National Institute of Health (NIH) 2014 Consensus Criteria. Eight organs - skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia were scored on a 0-3 scale to reflect degree of chronic GVHD involvement, where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 12 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months | Chronic GVHD was graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria. Eight organs- skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are scored on a 0-3 scale to reflect degree of chronic GVHD involvement where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 24 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD) | The presence of MRD was considered Detectable in participants who were FLT3/ITD MRD undetectable prior to randomization if log10-transformed overall FLT3/ITD mutation ratio greater than -4 otherwise presence of MRD was considered Not Detectable. Participants who had detectable FLT3/ITD MRD prior to randomization were considered eradicated if log10-transformed overall FLT3/ITD mutation ratio ≤ -4. Incidence of MRD Eradication and Detection were estimated using the cumulative incidence function, treating death during MRD assessment period without documentation of MRD event as competing risk. | ITT population with available data was analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 64 months and 22 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Relapse | Cumulative incidence of relapse was reported, treating death in remission as a competing risk. Relapse was defined as documentation of any of the following events:
| ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization up to 64 months and 22 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Infection by Severity. | Severity of Infection was assessed based on the following criteria: Grade 1-Mild Asymptomatic or mild symptoms, clinical or diagnostic observations noted intervention not indicated. Grade 2-Moderate Local or noninvasive intervention indicated. Grade 3-Severe Medically significant but not immediately life threatening, hospitalization or prolonged hospitalization. Grade 4-Life Threatening Life threatening consequences, urgent intervention indicated. Grade 5-Death related to the AE. Cumulative incidence of grade 3 to 5 infections were reported, treating death (grade 5) as a competing event. Treatment emergent was defined as an event observed through 30 days after the last dose. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization through 30 days after the last dose, up to 25 months and 22 days |
|
All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days
Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gilteritinib | Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met. | 42 | 178 | 92 | 178 | 175 | 178 |
| EG001 | Placebo | Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met. | 44 | 177 | 81 | 177 | 169 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Antithrombin III deficiency | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA v23 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA v23 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Polyserositis | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute graft versus host disease in liver | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease in lung | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis allergic | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Central nervous system infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cystitis bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viral haemorrhagic cystitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Large granular lymphocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Leukaemic retinopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Motor neurone disease | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v23 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Vulvovaginal adhesion | Reproductive system and breast disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Miscarriage of partner | Social circumstances | MedDRA v23 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridial sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Genital infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oesophageal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viral sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viral skin infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Global Development, Inc | 8008887704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2023 | May 6, 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 |
Not provided
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 |
|
| RIC/NMA |
|
| 61-90 days |
|
| Absent/Unknown |
|
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