Decitabine and Selinexor in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02093403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2017-12-08
Summary
This phase I trial studies the side effects and best dose of Selinexor when given together with decitabine in treating patients with acute myeloid leukemia that has returned after treatment (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Conditions
- Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
Interventions
- DRUG
-
decitabine
Given IV
- DRUG
-
Given PO
- OTHER
-
pharmacological study
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
Karyopharm Therapeutics Inc
collaborator INDUSTRY -
Bhavana Bhatnagar
lead OTHER
Principal Investigators
-
Bhavana Bhatnagar, DO · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2016-11-26
- Completion
- 2016-11-26
Countries
- United States
Study Locations
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