Trial · NCT03182244
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
NCT03182244, Phase 3, Completed, Astellas Pharma Inc; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation. Trials, record NCT03182244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03182244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
- NCT number
- NCT03182244
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- AML With FLT3 Mutation
- Interventions
- Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF, Fludarabine
- First posted
- 2017-06-09
- Last updated
- 2026-09-22
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of randomization up to the date of death (up to approximatley 74 months) | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were still alive or lost to follow up were censored at the time they were last known to be alive. Kaplan-Meier (KM) estimates was used for analysis. |
| Secondary | Event-Free Survival (EFS) | From the date of randomization up to the date of documented relapse, treatment failure or death from any cause, off-treatment relapse and start of new AML therapy (up to approximately 74 months) | EFS: time from the date of randomization until the date of documented relapse, treatment failure, death, reported off treatment relapse or new AML therapy start whichever occued first, including the long-term follow-up data. KM estimate was used for analysis. Relapse was defined as documentation of any of following events: * Bone marrow (BM) blasts ≥ 5% (not attributable to regenerating BM) * Reappearance or new appearance of extramedullary leukemia * Reappearance of significant numbers of peripheral blasts Treatment failure: Treatment failure was defined as participant who ends treatment without having a previous response of CR, CR with incomplete platelet recovery (CRp) and CR with incomplete hematological recover (CRi). |
| Secondary | Complete Remission (CR) Rate | From the date of randomization up to approximately 74 months | Percentage of participants with CR were reported. CR: morphologically leukemia-free state, with absolute neutrophil count (ANC) \> 1x10\^9 per liter (1x10\^9/L), platelet count ≥ 100x10\^9/L and normal marrow differential with \<5% blasts. They were red blood cell (RBC) and platelet transfusion independent and no evidence of extramedullary leukemia or Auer rods was necessary. |
| Secondary | Duration of CR | From date of achieving CR until date of confirmed relapse (maximum duration was 53.4 months ) | Duration of CR: time from the date of achieving first CR until date of first documented relapse for participants who achieved CR. KM estimate was used for analysis. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \< 5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. Relapse was defined as documentation of any of following events: * BM blasts ≥ 5% (not attributable to regenerating BM) * Reappearance or new appearance of extramedullary leukemia * Reappearance of significant numbers of peripheral blasts |
| Secondary | Duration of Composite Complete Remission (CRc) | From date of achieving CRc until date of confirmed relapse (maximum duration was 60 months) | Duration of CRc: time from date of achieving first CRc until date of first documented relapse for participants who achieved CRc. KM estimate was used for analysis. CRc: rate of all complete \& incomplete remissions \[CR + CRp + CRi\]. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \<5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. CRp: met all CR criteria except incomplete platelet recovery (\< 100x10\^9/L). CRi: met all CR criteria, except for incomplete hematological recovery with residual neutropenia \< 1x10\^9/L with or without complete platelet recovery. Relapse: BM blasts ≥ 5%, reappearance or new appearance of extramedullary leukemia, reappearance of significant numbers of peripheral blasts. |
| Secondary | Duration of CR/Complete Remission With Partial Hematologic Recovery (CRh) | From date of achieving CR/CRh until date of confirmed relapse (maximum duration was 58.1 months) | Duration of CR/CRh: time from date of achieving first CR/CRh until date of first documented relapse for participants who achieved CR/CRh. KM estimate was used for analysis. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \<5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5x10\^9/L and platelets ≥ 50x10\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: BM blasts ≥ 5%, reappearance or new appearance of extramedullary leukemia, reappearance of significant numbers of peripheral blasts. |
| Secondary | Duration Of Response (DOR) | From date of achieving CRc/PR until date of confirmed relapse (maximum duration was 52.1 months) | DOR: time from date of first CRc (CR+CRp+CRi)/PR until date of first documented relapse for participants who achieved CRc or PR. KM estimate used for analysis. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \<5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. CRp: met all CR criteria except incomplete platelet recovery (\< 100x10\^9/L). CRi: met all CR criteria, except for incomplete hematological recovery with residual neutropenia \< 1x10\^9/L with or without complete platelet recovery. PR: condition with regeneration of normal hematopoietic cells in BM, no detectable blasts, ≥ 50% decrease of blasts in BM aspirate \& total BM blasts of 5-25%. Relapse: BM blasts ≥ 5%, reappearance or new appearance of extramedullary leukemia, reappearance of significant numbers of peripheral blasts and increase in the percentage of blasts in the BM aspirate to \> 25%. |
| Secondary | CR/CRh Rate | From the date of randomization up to approximately 74 months | Percentage of participants with CR/CRh was reported. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \<5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5x10\^9/L and platelets ≥ 50x10\^9/L, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. |
| Secondary | Best Response Rate | From the date of randomization up to approximately 74 months | Defined as percentage of participants with CR, CRp, CRi, PR, no response (NR) \& not estimable (NE). CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L \& normal marrow differential with \< 5% blasts. They were RBC \& platelet transfusion independent \& no evidence of extramedullary leukemia. CRp: met all CR criteria except incomplete platelet recovery (\<100x10\^9/L). CRi: met all CR criteria, except incomplete hematological recovery with residual neutropenia \< 1x10\^9/L with/without complete platelet recovery. PR: condition with regeneration of normal hematopoietic cells in BM, no detectable blasts, ≥ 50% decrease of blasts in BM aspirate \& total BM blasts of 5-25%. \<=5% BM blasts if Auer rods are present, no evidence of extramedullary leukemia. Not Estimable (NE): No BM assessed/no myeloblast value, no blast value from peripheral blood or ≤2%, \& no extramedullary leukemia. No Response (NR): Response not categorized as CR, CRp, CRi, PR or NE. |
| Secondary | Leukemia-Fee Survival (LFS) | From first day of achieving first CRc to the first day of confirmed relapse/death (maximum duration was 60.0 months) | LFS: time from the date of first CRc (CR+CRp+CRi) until the date of documented relapse or death for participants who achieved CRc. CR: morphologically leukemia-free state, with ANC\> 1x10\^9/L, platelet count ≥ 100x10\^9/L and normal marrow differential with \< 5% blasts. They were RBC and platelet transfusion independent and no evidence of extramedullary leukemia. CRp: met all CR criteria except incomplete platelet recovery (\< 100x10\^9/L). CRi: met all CR criteria, except for incomplete hematological recovery with residual neutropenia \< 1x10\^9/L with or without complete platelet recovery. Relapse: BM blasts ≥ 5%, reappearance or new appearance of extramedullary leukemia, reappearance of significant numbers of peripheral blasts. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of randomization up to the date of death (up to approximatley 74 months) | ITT | months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) | From the date of randomization up to the date of documented relapse, treatment failure or death from any cause, off-treatment relapse and start of new AML therapy (up to approximately 74 months) | ITT | months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Duration of CR | From date of achieving CR until date of confirmed relapse (maximum duration was 53.4 months ) | ITT. Participants with CR were analyzed. | months | MEDIAN |
| SECONDARY | Duration of Composite Complete Remission (CRc) | From date of achieving CRc until date of confirmed relapse (maximum duration was 60 months) | ITT. Participants with best overall response of CRc were analyzed. | months | MEDIAN |
| SECONDARY | Duration of CR/Complete Remission With Partial Hematologic Recovery (CRh) | From date of achieving CR/CRh until date of confirmed relapse (maximum duration was 58.1 months) | ITT. Participants with CR/CRh were analyzed. | months | MEDIAN |
| SECONDARY | Duration Of Response (DOR) | From date of achieving CRc/PR until date of confirmed relapse (maximum duration was 52.1 months) | ITT. Participants with best overall response of CRc/PR were analyzed. | months | MEDIAN |
| SECONDARY | CR/CRh Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Best Response Rate | From the date of randomization up to approximately 74 months | ITT | Percentage of participants | NUMBER |
| SECONDARY | Leukemia-Fee Survival (LFS) | From first day of achieving first CRc to the first day of confirmed relapse/death (maximum duration was 60.0 months) | ITT. Participants with best overall response of CRc were analyzed. | months | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Gilteritinib | 10.3 | 95% Confidence Interval 8.8 to 12.7 | months | |
| Overall Survival (OS) | Salvage Chemotherapy | 5.4 | 95% Confidence Interval 4.1 to 8.1 | months | |
| Event-Free Survival (EFS) | Gilteritinib | 2.1 | 95% Confidence Interval 0.1 to 3.2 | months | |
| Event-Free Survival (EFS) | Salvage Chemotherapy | 0.6 | 95% Confidence Interval 0.2 to 1.2 | months | |
| Complete Remission (CR) Rate | Gilteritinib | 20.4 | 95% Confidence Interval 14.0 to 28.2 | Percentage of participants | |
| Complete Remission (CR) Rate | Salvage Chemotherapy | 11.5 | 95% Confidence Interval 6.7 to 18.0 | Percentage of participants | |
| Duration of CR | Gilteritinib | 24.0 | 95% Confidence Interval 4.6 to NA | months | |
| Duration of CR | Salvage Chemotherapy | NA | 95% Confidence Interval 1.0 to NA | months | |
| Duration of Composite Complete Remission (CRc) | Gilteritinib | 4.1 | 95% Confidence Interval 2.8 to 5.6 | months | |
| Duration of Composite Complete Remission (CRc) | Salvage Chemotherapy | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (Upto 1917 Days) | STARTED | Gilteritinib | 137 | |
| Treatment Period (Upto 1917 Days) | STARTED | Salvage Chemotherapy | 139 | |
| Treatment Period (Upto 1917 Days) | LoDAC | Gilteritinib | 0 | |
| Treatment Period (Upto 1917 Days) | LoDAC | Salvage Chemotherapy | 27 | |
| Treatment Period (Upto 1917 Days) | MEC | Gilteritinib | 0 | |
| Treatment Period (Upto 1917 Days) | MEC | Salvage Chemotherapy | 42 | |
| Treatment Period (Upto 1917 Days) | FLAG | Gilteritinib | 0 | |
| Treatment Period (Upto 1917 Days) | FLAG | Salvage Chemotherapy | 70 | |
| Treatment Period (Upto 1917 Days) | Chinese PK Cohort | Gilteritinib | 21 | |
| Treatment Period (Upto 1917 Days) | Chinese PK Cohort | Salvage Chemotherapy | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events456
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Gilteritinib | 99 | 134 | 719 |
| other | Anaemia | Blood and lymphatic system disorders | Salvage Chemotherapy | 79 | 119 | 394 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Gilteritinib | 3 | 134 | 4 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 8 | 119 | 11 |
| other | Leukocytosis | Blood and lymphatic system disorders | Gilteritinib | 25 | 134 | 53 |
| other | Leukocytosis | Blood and lymphatic system disorders | Salvage Chemotherapy | 14 | 119 | 18 |
| other | Leukopenia | Blood and lymphatic system disorders | Gilteritinib | 41 | 134 | 465 |
| other | Leukopenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 32 | 119 | 199 |
| other | Lymphopenia | Blood and lymphatic system disorders | Gilteritinib | 11 | 134 | 77 |
| other | Lymphopenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 14 | 119 | 103 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gilteritinib | 97 | 137 |
| Total, all-cause mortality | Salvage Chemotherapy | 85 | 139 |
| Total, other adverse events | Gilteritinib | 133 | 134 |
| Total, other adverse events | Salvage Chemotherapy | 113 | 119 |
| Total, serious adverse events | Gilteritinib | 102 | 134 |
| Total, serious adverse events | Salvage Chemotherapy | 71 | 119 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gilteritinib vs Salvage Chemotherapy: deaths from any cause | Trial comparisons |
| Gilteritinib vs Salvage Chemotherapy: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Gilteritinib vs Salvage Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03182244
GET https://conductscience.org/api/trials/v1/NCT03182244/registered?page=2