Phase 2
Completed N=317
Selinexor (KPT-330) in Older Patients With Relapsed AML
Source: ClinicalTrials.gov NCT02088541 ↗Enrolled (actual)
317
Serious AEs
73.1%
Results posted
Oct 2020
Primary outcomePrimary: Overall Survival — 94.0; 170.0 Days — p=0.4221
Summary
This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
94.0; 170.0 | 0.4221 |
| SECONDARY Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) |
53.49; 70.73 | 0.9464 |
| SECONDARY Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) |
5.1; 0 | 0.0986 |
| SECONDARY Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) |
121.0 | — |
| 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) |
11.9; 3.5 | 0.0844 |
| 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) |
175.0; 106.0 | — |
| SECONDARY Percentage of Participants With Overall Response Rate (ORR) |
13.6; 8.8 | — |
| SECONDARY Duration of Response (DOR) |
204.0; 148.0 | — |
| SECONDARY Percentage of Participants With Disease Control Rate (DCR) |
50.8; 40.4 | — |
| SECONDARY Duration of Disease Control Rate |
187.0; 233.0 | — |
| SECONDARY Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu] |
70.5; 75.4; 0.5; -1.9; -1.9; -5.4 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS) |
67.9; 63.5; -7.5; 0.8; -13.3; -5.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 60 years with relapsed or refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
- Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
- Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.
- At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.
Exclusion Criteria
- Treatment with any investigational agent within 3 weeks prior to first dose in this study.
- Presence of central nervous system (CNS) leukemia.
- In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
- Major surgery within 2 weeks of first dose of study drug. Participants must have recovered from the effects of any surgery performed greater than 2 weeks previously.
- Concurrent active malignancy under treatment.
- Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
- Known HIV infection.
- Unable to swallow tablets, or participants with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
- Participants whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.
Data sourced from ClinicalTrials.gov (NCT02088541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.