Phase 2
Completed N=42
A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov NCT02249091 ↗Enrolled (actual)
42
Serious AEs
47.6%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With CR/CRi = Overall Reponse Rate — 15; 6 Participants
Summary
Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several drugs with different ways of inhibiting the cell growth. In this trial, standard chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will be combined with a new drug called Selinexor.
Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus which control the cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With CR/CRi = Overall Reponse Rate |
15; 6 | — |
| SECONDARY Number of Participants With Partial Remission (PR) = Rate of PR |
0; 0 | — |
| SECONDARY Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation) |
11; 4 | — |
| SECONDARY Early Death Rate |
0; 4 | — |
| SECONDARY Overall Survival |
12.6; 8.0 | — |
| SECONDARY Relapse-Free Survival |
10.9; NA | — |
| SECONDARY Event-Free Survival |
5.6; 4.3 | — |
| SECONDARY Progression-Free Survival |
6.3; 4.3 | — |
Eligibility Criteria
Inclusion Criteria
- Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
- Patients must have relapsed/refractory disease (relapse after stem cell transplantation is permitted) as defined as:
- patients with /=50% (by echocardiography).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria
- Treatment with any investigational agent within four weeks.
- Cumulative anthracycline dose (daunorubicin or equivalent) >360 mg/m^2
- HIV infection
- Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to:
- Presence of CNS leukemia
- Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery.
- For patients after SCT as part of prior treatment:
- Necessity of immunosuppressive drugs
- GvHD > grade 1
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
- Ongoing cardiac dysrhythmias of NCI CTCAE >/= Grade 2.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Clinically significant bleeding within 1 month
Data sourced from ClinicalTrials.gov (NCT02249091). 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.