Trial · NCT02088541
Selinexor (KPT-330) in Older Patients With Relapsed AML
NCT02088541, Phase 2, Completed, Karyopharm Therapeutics Inc; results first posted 2020-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selinexor (KPT-330) in Older Patients With Relapsed AML. Trials, record NCT02088541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02088541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor (KPT-330) in Older Patients With Relapsed AML
- NCT number
- NCT02088541
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 317 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Selinexor, Hydroxyurea, Ara-C
- First posted
- 2014-03-17
- Last updated
- 2023-01-26
- Results first posted
- 2020-10-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. |
| Secondary | Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) | From randomization (Day 1) up to 3 months | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| Secondary | Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) \> 1000 cells/microliter (microL) and platelet count \> 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease. |
| Secondary | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. |
| Secondary | Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:\< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
| Secondary | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: \< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (\>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. CRp; All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required. |
| Secondary | Duration of Response (DOR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: \<5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL, platelet count \> 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count \> =1.0 x10\^9/L, platelet count \>= 100 x10\^9/L, \>= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (\<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), CRi; \< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS: morphologic bone marrow blast clearance to \< 5% in marrow sample, \<= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required. |
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for \<=4 weeks.CR:\<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC \>1000 cells/microL and platelet count \>100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count \>=1.0 x10\^9/L, Platelet count \>= 100\*10\^9/L, \>=50% reduction in BM blast to 6% to 25%, or blasts \<=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (\<1\*10\^9/L) or thrombocytopenia(\<100 x10\^9/L),CRi;\< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS:morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of \>4 weeks. |
| Secondary | Duration of Disease Control Rate | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | Duration of DCR calculated for all participants with DCR. CR: \< 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL and platelet count \> 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count \>=1.0 x 10\^9/L, Platelet count \>= 100 x 10\^9/L, \>= 50 % reduction in BM blast to 6% to 25%, or blasts \<= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L), CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS; morphologic BM blast clearance to \< 5% in a marrow sample in which \<=200 cells enumerated/cellularity is \>= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of \> 4 weeks. |
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 | Overall Survival | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | Intent-to-treat (ITT) population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) | From randomization (Day 1) up to 3 months | ITT population included all participants who were randomized to study treatment under PV \>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Percentage of participants | NUMBER |
| SECONDARY | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population:all participants who randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. This outcome measure(OM) was only defined for CR participants. For Physician Choice 2,there was zero CR participants.Overall Number of Participants Analyzed (N): Number of participants evaluable for this OM. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Percentage of participants | NUMBER |
| SECONDARY | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population included all participants who were randomized to study treatment under PV \>=5.0, regardless of whether or not they received study treatment. Here, N signifies number of participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Response Rate (ORR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. Here, N signifies number of participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control Rate (DCR) | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | ITT Population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Disease Control Rate | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. Here, N signifies number of participants evaluable for this measure. | Days | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 94.0 | 95% Confidence Interval 78.0 to 158.0 | Days | |
| Overall Survival | Physician's Choice 2 (PV >=5) | 170.0 | 95% Confidence Interval 111.0 to 220.0 | Days | |
| Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 53.49 | 95% Confidence Interval 43.54 to 62.44 | Percentage of participants | |
| Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) | Physician's Choice 2 (PV >=5) | 70.73 | 95% Confidence Interval 55.60 to 81.52 | Percentage of participants | |
| Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 5.1 | 95% Confidence Interval 1.9 to 10.7 | Percentage of participants | |
| Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) | Physician's Choice 2 (PV >=5) | 0 | 95% Confidence Interval 0.0 to 6.3 | Percentage of participants | |
| Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 121.0 | 95% Confidence Interval 49.0 to NA | Days | |
| Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 11.9 | 95% Confidence Interval 6.6 to 19.1 | Percentage of participants | |
| Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) | Physician's Choice 2 (PV >=5) | 3.5 | 95% Confidence Interval 0.4 to 12.1 | Percentage of participants | |
| Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 175.0 | 95% Confidence Interval 61.0 to 288.0 | Days |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 71 | |
| Overall Study | STARTED | Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2) | 27 | |
| Overall Study | STARTED | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 117 | |
| Overall Study | STARTED | Physician's Choice 1 (PV <5) | 44 | |
| Overall Study | STARTED | Physician's Choice 2 (PV >=5) | 58 | |
| Overall Study | Safety Population | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 71 | |
| Overall Study | Safety Population | Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2) | 27 | |
| Overall Study | Safety Population | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | 115 | |
| Overall Study | Safety Population | Physician's Choice 1 (PV <5) | 39 | |
| Overall Study | Safety Population | Physician's Choice 2 (PV >=5) | 45 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events3,390
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 | Nausea | Gastrointestinal disorders | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 41 | 71 | 41 |
| other | Nausea | Gastrointestinal disorders | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | 16 | 27 | 16 |
| other | Nausea | Gastrointestinal disorders | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | 68 | 115 | 68 |
| other | Nausea | Gastrointestinal disorders | Physician's Choice 1 (PV <5) | 13 | 39 | 13 |
| other | Nausea | Gastrointestinal disorders | Physician's Choice 2 (PV >=5) | 8 | 45 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 17 | 71 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | 13 | 27 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | 41 | 115 | 41 |
| other | Diarrhoea | Gastrointestinal disorders | Physician's Choice 1 (PV <5) | 8 | 39 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Physician's Choice 2 (PV >=5) | 6 | 45 | 6 |
1 to 10 of 3,390Source ClinicalTrials.gov
See all 3,390 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 24 | 71 |
| Total, all-cause mortality | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | 3 | 27 |
| Total, all-cause mortality | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | 28 | 115 |
| Total, all-cause mortality | Physician's Choice 1 (PV <5) | 7 | 39 |
| Total, all-cause mortality | Physician's Choice 2 (PV >=5) | 9 | 45 |
| Total, other adverse events | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | 71 | 71 |
| Total, other adverse events | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | 27 | 27 |
| Total, other adverse events | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | 113 | 115 |
| Total, other adverse events | Physician's Choice 1 (PV <5) | 37 | 39 |
| Total, other adverse events | Physician's Choice 2 (PV >=5) | 40 | 45 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34323164 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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