Trial · NCT02421939
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
NCT02421939, Phase 3, Completed, Astellas Pharma Global Development, Inc.; results first posted 2019-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation. Trials, record NCT02421939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02421939
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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 (FLT3) Mutation
- NCT number
- NCT02421939
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 371 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Leukemia, Acute Myeloid (AML)
- Interventions
- gilteritinib, LoDAC (Low Dose Cytarabine), Azacitidine, MEC (Mitoxantrone, Etoposide, Cytarabine), FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
- First posted
- 2015-04-21
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2015-000140-42
- Results first posted
- 2019-10-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Overall Survival (OS) | From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months) | Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was 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 - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula. |
| Primary | Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | From the date of randomization up to at least 112 days | The CR/CRh rate was defined as the number of participants who achieved either CR or CRh divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: Participants were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR. |
| Secondary | Duration of Event-Free Survival (EFS) | From the date of randomization until the date of documented relapse, treatment failure or death from any cause (median time of follow-up was 17.8 months) | EFS: time from randomization date up to date of documented relapse (excluding relapse after PR)/ treatment failure (failure to achieve CR, CRp, CRi /PR) /death, whichever occurred first. Relapse: leukemic blasts in peripheral blood 5/ ≥ 25% blasts in bone marrow (BM) aspirate due to no other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10\^9/L, platelet count ≥100x10\^9/L, normal marrow differential with \<5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (\<100x 0\^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia \<1x10\^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. |
| Secondary | Percentage of Participants With Complete Remission (CR) Rate | From the date of randomization up to at least 6 months | The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. |
| Secondary | Duration of Leukemia-Free Survival (LFS) | From the date of first CRc until the date of documented relapse or death for participants who achieved CRc (median time of follow-up was 17.8 months) | LFS: time from the date of first CRc until the date of documented relapse or death for subjects who achieve CRc. For a subject who is not known to have relapsed or died, LFS is censored on the date of last relapse-free disease assessment date. CRc: achieved CR, CRp or CRi. Relapse: leukemic blasts in peripheral blood/ ≥ 25% blasts in bone marrow (BM) aspirate not due to any other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥ 1 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal marrow differential with \< 5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (\< 100 x 10\^9/L). CRi : criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia \< 1 x 10\^9/L with /without complete platelet recovery.. |
| Secondary | Duration of Remission | From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months) | Duration of remission included duration of CRc, CR/CRh, CRh, CR, CRi, CRp (defined as the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR/CRh, CRh, CR, CRi, CRp respectively) and duration of response (CRc + PR). CRc: achieved CR, CRp or CRi at the visit. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10\^9/L, platelet count ≥100x10\^9/L, normal marrow differential with \<5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (\<100x 0\^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia \<1x10\^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. |
| Secondary | Percentage of Participants With Composite Complete Remission (CRc Rate) | From the date of randomization up to at least 6 months | CRc rate: Number of participants with best response of CRc (CR,complete remission with incomplete platelet recovery \[CRp\] or complete remission with incomplete hematologic recovery \[CRi\]) divided by number of participants in the analysis population. CRc : Participants who achieved CR, CRp or CRi at a post-baseline visit. CR: Participants having bone marrow regenerating normal hematopoietic cells, a morphologic leukemia-free state, an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L, normal marrow differential with \< 5% blasts, and being RBC and platelet transfusion independent with no evidence of extramedullary leukemia at a post-baseline visit. CRp: Participants achieving CR except for incomplete platelet recovery (\< 100 x 10\^9/L) at a post-baseline visit. CRi : Participants, who fulfilled all criteria for CR except incomplete hematological recovery with residual neutropenia \< 1 x 10\^9/L with or without complete platelet recovery at a post-baseline visit. |
| Secondary | Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant | From the date of randomization until end of study (median time of follow-up was 17.8 months) | Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period. |
| Secondary | Change From Baseline in Brief Fatigue Inventory (BFI) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | The Brief Fatigue Inventory (BFI) was a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions asked participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions asked participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The total score range is 0-10 with a higher BFI fatigue score indicates worse outcome. The global BFI score was calculated only if at least 5 of the 9 items are answered. |
| Secondary | Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh) | From the date of randomization up to at least 6 months | CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at a post-baseline visit, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: At a post baseline visit, participantss were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Overall Survival (OS) | From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months) | The analysis population was the Intention to Treatment (ITT) which consisted of all randomized participants. | Months | MEDIAN |
| PRIMARY | Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | From the date of randomization up to at least 112 days | The analysis population was the response analysis set (RAS) which consisted of participants who were who were at least 112 days past the first dose of gilteritinib or randomization (for participants who did not receive gilteritinib). The participants were analyzed based on the randomized treatments. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Event-Free Survival (EFS) | From the date of randomization until the date of documented relapse, treatment failure or death from any cause (median time of follow-up was 17.8 months) | The analysis population was the ITT with available data. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) Rate | From the date of randomization up to at least 6 months | The analysis population was the ITT. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Leukemia-Free Survival (LFS) | From the date of first CRc until the date of documented relapse or death for participants who achieved CRc (median time of follow-up was 17.8 months) | The analysis population was the ITT, with participants with best response of CRc. | Months | MEDIAN |
| SECONDARY | Duration of Remission | From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months) | The analysis population was the ITT, Duration of CR was only applicable to participants with best overall response of CR. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Composite Complete Remission (CRc Rate) | From the date of randomization up to at least 6 months | The analysis population was the ITT. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant | From the date of randomization until end of study (median time of follow-up was 17.8 months) | The analysis population is the ITT. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Fatigue Inventory (BFI) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | The analysis population was the ITT, with participants with data at baseline. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh) | From the date of randomization up to at least 6 months | The analysis population was the ITT. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Overall Survival (OS) | Gilteritinib | 9.3 | 95% Confidence Interval 7.7 to 10.7 | Months | |
| Duration of Overall Survival (OS) | Salvage Chemotherapy | 5.6 | 95% Confidence Interval 4.7 to 7.3 | Months | |
| Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | Gilteritinib | CR/CRh rate | 28.2 | 95% Confidence Interval 20.9 to 36.3 | Percentage of participants |
| Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | Gilteritinib | CR rate | 19.0 | 95% Confidence Interval 12.9 to 26.4 | Percentage of participants |
| Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | Gilteritinib | CRh rate | 9.2 | 95% Confidence Interval 5.0 to 15.1 | Percentage of participants |
| Duration of Event-Free Survival (EFS) | Gilteritinib | 2.8 | 95% Confidence Interval 1.4 to 3.7 | Months | |
| Duration of Event-Free Survival (EFS) | Salvage Chemotherapy | 0.7 | 95% Confidence Interval 0.2 to NA | Months | |
| Percentage of Participants With Complete Remission (CR) Rate | Gilteritinib | 21.1 | 95% Confidence Interval 16.1 to 26.7 | Percentage of participants | |
| Percentage of Participants With Complete Remission (CR) Rate | Salvage Chemotherapy | 10.5 | 95% Confidence Interval 5.7 to 17.3 | Percentage of participants | |
| Duration of Leukemia-Free Survival (LFS) | Gilteritinib | 4.4 | 95% Confidence Interval 3.6 to 5.2 | Months |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Period: Up to 3 Years | STARTED | Gilteritinib | 247 | |
| Randomization Period: Up to 3 Years | STARTED | Salvage Chemotherapy | 124 | |
| Randomization Period: Up to 3 Years | Treated | Gilteritinib | 246 | |
| Randomization Period: Up to 3 Years | Treated | Salvage Chemotherapy | 109 | |
| Randomization Period: Up to 3 Years | COMPLETED | Gilteritinib | 0 | |
| Randomization Period: Up to 3 Years | COMPLETED | Salvage Chemotherapy | 19 | |
| Randomization Period: Up to 3 Years | NOT COMPLETED | Gilteritinib | 247 | |
| Randomization Period: Up to 3 Years | NOT COMPLETED | Salvage Chemotherapy | 105 | |
| Long Term Follow up: up to 3 Years | STARTED | Gilteritinib | 133 | |
| Long Term Follow up: up to 3 Years | STARTED | Salvage Chemotherapy | 73 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events772
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 | 112 | 246 | 493 |
| other | Anaemia | Blood and lymphatic system disorders | Salvage Chemotherapy | 38 | 109 | 80 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Gilteritinib | 8 | 246 | 9 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Salvage Chemotherapy | 6 | 109 | 6 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Gilteritinib | 57 | 246 | 73 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 32 | 109 | 37 |
| other | Neutropenia | Blood and lymphatic system disorders | Gilteritinib | 32 | 246 | 115 |
| other | Neutropenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 16 | 109 | 18 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gilteritinib | 62 | 246 | 301 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Salvage Chemotherapy | 17 | 109 | 41 |
1 to 10 of 772Source ClinicalTrials.gov
See all 772 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gilteritinib | 204 | 247 |
| Total, all-cause mortality | Salvage Chemotherapy | 96 | 124 |
| Total, other adverse events | Gilteritinib | 242 | 246 |
| Total, other adverse events | Salvage Chemotherapy | 103 | 109 |
| Total, serious adverse events | Gilteritinib | 211 | 246 |
| Total, serious adverse events | Salvage Chemotherapy | 34 | 109 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
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: 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.
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