Patients with relapsed/refractory Acute Myeloid Leukemia (AML) MedDRA version: 19.1 Level: LLT Classification code 10060558 Term: Acute myeloid leukemia recurrent System Organ Class: 100000004864 MedDRA version: 19.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864 MedDRA version: 19.1 Level: LLT Classification code 10066638 Term: Acute myeloid leukemia progression System Organ Class: 100000004864 MedDRA version: 19.1 Level: LLT Classifica
Conditions
Sponsors
GSO Global Clinical Research B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3) 2. Patients must have relapsed/refractory disease (relapse after stem cell transplantation is permitted) as defined as: patients with /=50% (by echocardiography). 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Treatment with any investigational agent within four weeks. 2. Cumulative anthracycline dose (daunorubicin or equivalent) >360 mg/m² 3. HIV infection 4. Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to: 5. Presence of CNS leukemia 6. Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery. 7. For patients after SCT as part of prior treatment: a. Necessity of immunosuppressive drugs b. GvHD > grade 1 8. 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. 9. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ?2. 10. 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. 11. Clinically significant bleeding within 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of Selinexor in combination with standard chemotherapy in patients with relapsed/ refractory AML by determination of rate of complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi), as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet;Secondary Objective: To determine the efficacy of Selinexor in combination with standard chemotherapy in patients with relapsed/ refractory AML by oRate of partial remissions oPercentage of patients being transplanted after induction therapy oEarly death rate oOverall survival (OS) oEvent-free survival •To evaluate overall safety and tolerability of Selinexor characterized by type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03), timing and relatedness of adverse events (AEs) and laboratory abnormalities observed during the treatment within this study ;Primary end point(s): Percentage of patients achieving a complete response (CR) or CRi (complete remission without normalization of peripheral blood counts);Timepoint(s) of evaluation of this end point: After 1st and 2nd cycle of induction therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Percentage of patients undergoing subsequent allogeneic stem cell transplant 2)Early death rate 3)Overall survival (OS) 4)Event-free survival (Events are defined as Death, not achieving a CR or CRi, Relapse after CR or CRi) 5)Toxicity (acc. to NCI CTC AE v4.03) ;Timepoint(s) of evaluation of this end point: 1) After induction therapy completed 2)Early death rate 3)2 years after last patient registered 4)2 years after last patient registered 5)Treatment start to 30 days after last treatment with Selinexor | — |
Countries
Germany
Contacts
Public ContactProjectmanagement
GSO Global Clinical Research B.V.
Outcome results
None listed