Acute Myeloid Leukemia (AML)Phase 2NCT02927262
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
A Phase 2 study testing Gilteritinib in people with Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation, run by Astellas Pharma Global Development, Inc. at 73 sites in 21 countries.
Trial summary
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
- What is being tested?
- Gilteritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 73 sitesin 21 countries
- Study dates
- 10 Jan 2017to 19 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is considered an adult according to local regulation at the time of obtaining consent form (ICF).
- Subject consents to allow access to subject's diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test for gilteritinib.
- Subject has confirmed morphologically documented AML, excluding acute promyelocytic leukemia (APL), in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
- Subject will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.
- Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
- Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.
Show all 28Show fewer
- Subject has had presence of the FLT3/ITD activating mutation in the bone marrow or peripheral blood as determined by the local institution at diagnosis.
- Subject has an ECOG performance status 0 to 2.
- Subject must meet the following criteria as indicated on the clinical laboratory tests:
- Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m^2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation.
- Serum total bilirubin ≤ 2.5 mg/dL (43 μmol/L), except for subjects with Gilbert's syndrome.
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN.
- Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).
- Absolute neutrophil count (ANC) ≥ 500/μl and platelets ≥ 20000/μl (unsupported by transfusions).
- Subject is suitable for oral administration of study drug.
- Female subject must either:
- Be of nonchildbearing potential:
- Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
- Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
- Or, if of childbearing potential,
- Agree not to try to become pregnant during the study and for 6 months after the final study drug administration
- And have a negative urine or serum pregnancy test at screening
- And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and throughout the study period and for 6 months after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- Male subject and subject's female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration.
- Subject agrees not to participate in another interventional study while on treatment.
Who cannot join
- Subject has had prior allogeneic transplant.
- Subject has QTcF interval > 450 msec (average of triplicate determinations based on central reading).
- Subject with Long QT Syndrome.
- Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).
- Subject has clinically active central nervous system leukemia.
- Subject is known to have human immunodeficiency virus infection.
Show all 16Show fewer
- Subject has active hepatitis B or C.
- Subject has an uncontrolled infection. If a bacterial or viral infection is present, the subject 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 subject must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
- Subject has progressing infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
- Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
- Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
- Subject 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 subject.
- Subject has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Subject has prior malignancies, except resected basal cell carcinoma 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.
- Subject has any condition which makes the subject unsuitable for study participation.
Trial locations and contacts
73 sites in 21 countries.
73 sites in 21 countries
Japan12 sites
Site JP81010
Aomori
Site JP81004
Kanazawa, Ishikawa-ken
Site JP81012
Kobe, Hyōgo
Site JP81025
Matsuyama, Ehime
Site JP81018
Nagoya, Aichi-ken
Site JP81017
Okayama
Site JP81024
Sapporo, Hokkaido
Site JP81014
Sendai, Miyagi
Site JP81023
Shimotsuke, Tochigi
Site JP81011
Tachikawa, Tokyo
Site JP81009
Yokohama, Kanagawa
Site JP81002
Yoshida-gun, Fukui
South Korea8 sites
Site KR82014
Bucheon-si, Gyeonggido, 14584
Site KR82006
Busan, 49241
Site KR82013
Goyang, Gyeonggido, 10408
Site KR82003
Hwasungun, Jeonranamdo, 58128
Site KR82008
Namdong, Incheon Gwang'yeogsiv, 405 760
Site KR82012
Seoul, Seoul Teugbyeolsi, 06351
Site KR82009
Seoul, 120-752
Site KR82005
Suwon, Gyeonggi-do, 16499
United Kingdom8 sites
Site GB44002
Birmingham, B95SS
Site GB44015
Cardiff, CF4 4XN
Site GB44006
Cottingham, East Riding Of Yorkshire, HU165JQ
Site GB44007
Exeter, Devon, EX2 5DW
Site GB44020
Leeds, LS9 7TF
Site GB44018
London, London, City of, WC1E 6BT
Site GB44004
Nottingham, NG5 1PB
Site GB44019
Plymouth, Devon, PL6 8DH
France7 sites
Site FR33001
Bayonne, 64100
Site FR33004
Brest, Finistere, 29609
Site FR33009
Mulhouse, 68070
Site FR33008
Nice, 06189
Site FR33007
Pierre-Bénite, Rhone, 69310
Site FR33002
Tours, Indre-et-Loire, 37044
Site FR33014
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
United States6 sites
Site US10012
Chicago, Illinois, 60612
Site US10017
Gainesville, Florida, 32610-0278
Site US10029
Greenville, South Carolina, 26615
Site US10030
Jacksonville, Florida, 32204
Site US10007
Portland, Oregon, 97239
Site US10025
Syracuse, New York, 13210
Italy6 sites
Site IT39008
Bergamo, 24127
Site IT39004
Castelfranco Veneto (TV), Treviso, 31033
Site IT39011
Milan, Lombardy, 20141
Site IT39005
Parma
Site IT39010
Reggio Emilia, 42100
Site IT39002
Roma, 161
Greece4 sites
Site GR30010
Athens, Attica, 10676
Site GR30009
Athens
Site GR30007
Larissa
Site GR30004
Thessaloniki, Central Macedonia, 57010
Poland3 sites
Site PL48002
Bydgoszcz, 85-168
Site PL48001
Olsztyn, Warmian-Masurian Voivodeship, 10-228
Site PL48007
Poznan
Taiwan3 sites
Site TW88605
Kaohsiung City, 112
Site TW88604
Kaohsiung City, 83301
Site TW88603
Taipei, 114
Canada2 sites
Site CA15001
Halifax, Nova Scotia, B3H2Y9
Site CA15003
Toronto, Ontario, M5G 2M9
Germany2 sites
Site DE49001
Duisburg, North Rhine-Westphalia, 47166
Site DE49008
Stuttgart, 70376
Sweden2 sites
Site SE46002
Lund, 221 85
Site SE46003
Stockholm, Stockholm County, 171 76
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.
Read the detailed description
Participants in CR1 were approached for this study after induction/consolidation therapy was complete and a decision not to proceed with transplantation was made or a suitable donor could not be identified. Participants were randomized in a 2:1 ratio to receive gilteritinib or placebo. Participants entered the screening period up to 14 days prior to the start of treatment. Participants were administered treatment over continuous 28-day cycles. Gilteritinib or placebo was given daily for up to 2 years. After treatment discontinuation, participants had a 30-day follow-up visit for safety, after which the participants entered the long-term follow up period for collection of subsequent AML treatment, remission status, and survival (cause of death and date of death). Final database lock will occur when last subject last follow-up visit is reached, per protocol. Study drug was not provided during the follow-up period.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
- Being tested
- Gilteritinib, Placebo
- Keywords
- Acute myeloid leukemia, First Complete Remission, gilteritinib, FLT3/ITD, AML, ASP2215
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilteritinibDrug
Also called ASP2215
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Gilteritinib | Experimental | Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-specified discontinuation criterion was met. Receives: Drug: Gilteritinib |
| Placebo | Placebo comparator | Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-specified discontinuation criterion was met. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free Survival (RFS) Per Independent Review Committee (IRC) Adjudication
RFS was defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurred first. Relapse after complete remission (CR) [including complete remission with incomplete platelet recovery (CRp) and Complete remission with incomplete hematologic recovery (CRi)], was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised International Working Group (IWG) criteria.
Participants were classified as:
CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required.
CRp, if they achieved CR except for incomplete platelet recovery (< 100 × 10^9/L).
RFS was estimated using Kaplan-Meier estimates. hazard ratio (HR), cox proportional hazards model (CHM)
Measured: From the date of randomization until the date of documented relapse, or death; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)
Secondary outcomes (5)
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meiers method.
Measured: From the date of randomization until the date of death from any cause; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)
Event-Free Survival (EFS)
EFS was defined as the time from the date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first. Relapse after CR (including CRp and CRi), was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised IWG criteria.
Participants were classified as:
CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required.
CRp, if they achieved CR except for incomplete platelet recovery (< 100 × 10^9/L).
EFS was estimated using Kaplan-Meier's method.
Measured: From date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause; (Median time on study drug was 427 days for gilteritinib and 212 days for Placebo)
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT)
MRD was measured from bone marrow samples. FLT3/ITD mutation ratio was measured in relation to total FLT3. For a participant with multiple ITD mutations, the overall FLT3/ITD mutation ratio was calculated from the sum of all ITD mutations. Absence of Minimal Residual Disease (MRD) is defined as log10-transformed overall FLT3/ITD mutation ratio ≤ -4.
Measured: Baseline and months 3, 6, 12, 24/EoT
Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a participant administered a study drug, which does not necessarily have to have a causal relationship with treatment. It can, be any unfavorable and unintended sign, symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether considered related to the medicinal product. An AE is considered "serious" if, it results in results in death, is life-threatening (an AE is considered "life-threatening" if, its occurrence places the participant at immediate risk of death, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, Requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization.
TEAE was defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Measured: From first dose date up to 30 days after last dose or data cut-off date 25-May 2021 (Maximum treatment duration was 744 days)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score
ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- Dead.
Number of participants with ECOG PS was reported. ECOG PS grades with zero participants were not reported.
Measured: Months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/EoT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study start10 Jan 2017
- Primary completion25 May 2021
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927262
- Sponsor's protocol ID
- 2215-CL-0302
- Other IDs
- 2016-001643-39, 2016
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2016
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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/.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission
- ClinicalTrials.gov ID
- NCT02927262
- Acronym / sponsor ID
- 2215-CL-0302
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
- Keywords
- Acute myeloid leukemia, First Complete Remission, gilteritinib, FLT3/ITD, AML, ASP2215
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Posted 27 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.
Detailed description
Participants in CR1 were approached for this study after induction/consolidation therapy was complete and a decision not to proceed with transplantation was made or a suitable donor could not be identified. Participants were randomized in a 2:1 ratio to receive gilteritinib or placebo. Participants entered the screening period up to 14 days prior to the start of treatment. Participants were administered treatment over continuous 28-day cycles. Gilteritinib or placebo was given daily for up to 2 years. After treatment discontinuation, participants had a 30-day follow-up visit for safety, after which the participants entered the long-term follow up period for collection of subsequent AML treatment, remission status, and survival (cause of death and date of death). Final database lock will occur when last subject last follow-up visit is reached, per protocol. Study drug was not provided during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gilteritinib | Experimental | Drug: GilteritinibParticipants received gilteritinib 120 mg (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-specified discontinuation criterion was met. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-specified discontinuation criterion was met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject is considered an adult according to local regulation at the time of obtaining consent form (ICF).
- Subject consents to allow access to subject's diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test for gilteritinib.
- Subject has confirmed morphologically documented AML, excluding acute promyelocytic leukemia (APL), in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
- Subject will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.
- Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
Key exclusion criteria (16 listed)
- Subject has had prior allogeneic transplant.
- Subject has QTcF interval > 450 msec (average of triplicate determinations based on central reading).
- Subject with Long QT Syndrome.
- Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).
- Subject has clinically active central nervous system leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GilteritinibAlso: ASP2215Oral tablet | Drug | Gilteritinib |
| PlaceboOral tablet | Drug | Placebo |
Primary outcome
Relapse-free Survival (RFS) Per Independent Review Committee (IRC) Adjudication
Time frame: From the date of randomization until the date of documented relapse, or death; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)
RFS was defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurred first. Relapse after complete remission (CR) [including complete remission with incomplete platelet recovery (CRp) and Complete remission with incomplete hematologic recovery (CRi)], was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised International Working Group (IWG) criteria. Participants were classified as: CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required. CRp, if they achieved CR except for incomplete platelet recovery (< 100 × 10^9/L). RFS was estimated using Kaplan-Meier estimates. hazard ratio (HR), cox proportional hazards model (CHM)
5 secondary outcomes
Overall Survival (OS)
Time frame: From the date of randomization until the date of death from any cause; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)
Event-Free Survival (EFS)
Time frame: From date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause; (Median time on study drug was 427 days for gilteritinib and 212 days for Placebo)
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT)
Time frame: Baseline and months 3, 6, 12, 24/EoT
Number of Participants With Adverse Events (AE)
Time frame: From first dose date up to 30 days after last dose or data cut-off date 25-May 2021 (Maximum treatment duration was 744 days)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score
Time frame: Months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/EoT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/.
Related trials for Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Medical Director study director
Astellas Pharma Global Development, Inc.
73 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gilteritinib in people with Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation, run by Astellas Pharma Global Development, Inc. at 73 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Japan, South Korea, United Kingdom, France, United States and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free Survival (RFS) Per Independent Review Committee (IRC) Adjudication (time frame: From the date of randomization until the date of documented relapse, or death; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.