Selinexor (KPT-330) in Older Patients With Relapsed AML
Conditions
Acute Myeloid Leukemia (AML)
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Relapsed/Refractory Acute Myeloid Leukemia, Acute Myeloid Leukemia, AML, Karyopharm, Selinexor, KPT-330
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Selinexor Type: Drug
Name: Hydroxyurea Type: Drug
Name: Ara-C Type: Drug
Name: azacitidine Type: Drug
Name: Decitabine Type: Drug
Overall Status
Recruiting
Summary
This is a randomized, multicenter, open-label, Phase 2 study of the SINE Selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Patients age ≥ 60 years with relapsed/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.
Detailed Description
This is a randomized, multicenter, open-label phase 2 study of the SINE Selinexor given orally versus restricted investigator choice (i.e., one of three potential salvage therapies).

Patients who have never been transplant eligible, are currently deemed unfit for intensive chemotherapy, ≥ 60 years old, who have AML (except Acute Promyelocytic Leukemia: APL, AML M3) after one prior treatment of either hypomethylating agent or a regimen including Ara-C, and are meeting the inclusion and exclusion criteria will be randomized to receive either oral Selinexor or physician's choice (one of three potential treatments: best supportive care (BSC) alone, or BSC + hypomethylating agent, or BSC + low dose Ara-C until disease progression, death or intolerance has occurred.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age ≥ 60 years with relapsed/refractory AML of any type except for AML M3, after 1 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.

- 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 only 1 prior line of therapy given at standard doses. Prior therapy must have included: (1) A regimen including cytosine arabinoside (Ara-C) chemotherapy (low dose AraC alone does qualify for prior chemotherapy) or (2) a hypomethylating agent.

- 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. Patients 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 patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
Locations
Jonsson Comprehensive Cancer Center / University of California, Los Angeles
Los Angeles, California, United States
Status: Not yet recruiting
Contact: Gary Schiller - 888-798-0719
Sutter Oncology & Hematology
Sacramento, California, United States
Status: Not yet recruiting
Contact: Michael Carroll - 877-494-3444 - SIMR@sutterhealth.org
Stanford Cancer Institute / Stanford University
Stanford, California, United States
Status: Not yet recruiting
Contact: Bruno Medeiros - 650-498-7061 - ccto-office@stanford.edu
Colorado Blood Cancer Institute/Sarah Cannon Research Institute
Denver, Colorado, United States
Status: Recruiting
Contact: Michael Maris, MD - 720-754-4800
Yale Cancer Center / Yale University
New Haven, Connecticut, United States
Status: Not yet recruiting
Contact: Steven Gore - 855-476-4569
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Status: Recruiting
Contact: Kendra Sweet - 888-663-3488
Winship Cancer Institute / Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Vamsi Kota - 404-778-1868 - winshipcto@emory.edu
Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Olga Frankfurt, MD - 312-503-7955
University of Chicago Medicine
Chicago, Illinois, United States
Status: Recruiting
Contact: Hongtao Liu, M.D., Ph.D. - 773-702-1000
University of Kansas Hospital
Kansas City, Kansas, United States
Status: Not yet recruiting
Contact: Tara Lin - 913-588-1227
Sidney Kimmel Comprehensive Cancer Center / John Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
Contact: Margaret Showel - 410-955-8964
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Jan Cerny, MD - 508-856-8989
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Dale Bixby, MD - 800-865-1125
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Stefan Faderl, MD - 201-996-2000
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Eunice Wang - 877-275-7724
Westchester Medical Center / New York Medical College
Hawthorne, New York, United States
Status: Not yet recruiting
Contact: Karen Seiter - 914-493-2007
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Not yet recruiting
Contact: Virginia Klimek - 212-639-2000
New York Presbyterian Hospital / Weill Cornell Medical College
New York, New York, United States
Status: Recruiting
Contact: Gail Roboz, MD - 212-746-5454
Duke Cancer Care
Durham, North Carolina, United States
Status: Not yet recruiting
Contact: David Rizzieri - 919-684-8964
Gabrail Cancer Center
Canton, Ohio, United States
Status: Recruiting
Contact: Nashat Gabrail, M.D. - 330-492-3345
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: William Blum, MD - 614-293-5066
Milton S. Hershey Medical Center / Penn State
Hershey, Pennsylvania, United States
Status: Recruiting
Contact: Hong Zheng - 800-243-1455
Tennessee Oncology/Sarah Cannon Research Institute
Nashville, Tennessee, United States
Status: Recruiting
Contact: Ian Flinn, MD - 877-691-7274 - asksarah@sarahcannon.com
Vanderbilt-Ingram Cancer Center / Vanderbilt University
Nashville, Tennessee, United States
Status: Recruiting
Contact: Stephen Strickland, MD - 877-936-8422
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Status: Recruiting
Contact: Michael Andreeff - 877-632-6789
Texas Transplant Institute/Sarah Cannon Research Institute
San Antonio, Texas, United States
Status: Recruiting
Contact: Carlos Bachier - 877-330-2919
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Contact: Lynn Savoie, MD - 403-521-3723
University of Alberta
Edmonton, Alberta, Canada
Status: Not yet recruiting
Contact: Joseph Brandwein - (780) 407-6179 - trials@nactrc.ca
Sir Mortimer B. Davis Jewish General Hospital / McGill University
Montreal, Quebec, Canada
Status: Not yet recruiting
Contact: John Storring - 514-340-8222
Aarhus University Hospital
Aarhus, Denmark
Status: Recruiting
Contact: Ingrid Gejel - 7845 0000
Department of Haematology, National University Hospital, Rigshospitalet
Copenhagen, Denmark
Status: Recruiting
Contact: Lars Kjeldsen - +45 3545 3545
Herlev Hospital
Herlev, Denmark
Status: Recruiting
Contact: Birgitte Jorgensen - +45 38 68 38 68
Odense University Hospital, Department of Hematology
Odense, Denmark
Status: Recruiting
Contact: Sally Grant - 66 11 33 33
Stellvertretende Klinikleiterin Charité, Campus Benjamin Franklin
Berlin, Germany
Status: Not yet recruiting
Contact: Claudia Baldus - +49 30 8445 - 0
Ev. Diakonie-Krankenhaus Gemeinnutzige GMBH Medizinische Klinik 2
Bremen, Germany
Status: Recruiting
Contact: Ralf-Ulrich Trappe - 0421 61 02 - 1 401
UNIVERSITÄTSKLINIKUM TU DRESDEN Medizinische Klinik und Poliklinik I,
Dresden, Germany
Status: Recruiting
Contact: Christoph Roellig - +49 (0) 351 458 - 0
University Hospital Frankfurt
Frankfurt, Germany
Status: Not yet recruiting
Contact: Christian Brandts - + 49 69 / 6301-0
Medizinische Hochschule Hannover (Hannover Medical School) Dept. of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation
Hanover, Germany
Status: Recruiting
Contact: Michael Heuser - +49 511 532-0
Abteilung Hämatologie, internistische Onkologie und Hämostaseologie
Leipzig, Germany
Status: Recruiting
Contact: Dietger Niederwieser - 0341/97-13050
UNIVERSITY HOSPITAL OF MÜNSTER Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster
Münster, Germany
Status: Recruiting
Contact: Tim Sauer - (02 51) 83 - 0
Universitätsklinikum Ulm
ULM, Germany
Status: Recruiting
Contact: Hartmut Doehner - 0731 / 5000
Sororka MC
Beer Sheva, Israel
Status: Not yet recruiting
Contact: Itai Levi - 08-6400309
Rambam Health Care Campus
Haifa, Israel
Status: Not yet recruiting
Contact: Yishai Ofran - 1-700-50-51-50
Wolfson Medical Center
Holon, Israel
Status: Recruiting
Contact: Asher Winder - +972 3-502-8211
Hadassah Medical Center
Jerusalem, Israel
Status: Not yet recruiting
Contact: Dina Ben-Yehuda - +972-2-6777111
Rabin Medical Center
Petach Tikva, Israel
Status: Not yet recruiting
Contact: Ronit Gurion - 03-9377377
Tel Aviv Sourasky Medical Centre
Tel Aviv, Israel
Status: Recruiting
Contact: Ornit Dekel - +972-3-697-4444
Chaim Sheba Medical Center
Tel Hashomer, Israel
Status: Not yet recruiting
Contact: Arnon Nagler - +972-3-530-3030
AMC, Academisch Medisch Centrum Afdeling Klinische Hematologie
Amsterdam, Netherlands
Status: Recruiting
Contact: B. J. Biemond - 020 - 566 9111
VU University Medical Center
Amsterdam, Netherlands
Status: Recruiting
Contact: Gert Ossenkoppele - (020) 44 44444
Universitair Medisch Centrum Groningen Department of Haematology
Groningen, Netherlands
Status: Recruiting
Contact: E Vallenga - +31 (50) 361 61 61
Radboud University Medical Center Department of Haematology (476)
Nijmegen, Netherlands
Status: Recruiting
Contact: Gerwin Huls - +31 (0) 24 361 47 62
Erasmus MC, location Daniel den Hoed
Rotterdam, Netherlands
Status: Recruiting
Contact: Mojca Jongen-Lavrencic - 010 704 0 704
University Medical Center Utrecht
Utrecht, Netherlands
Status: Not yet recruiting
Contact: M. A. de Witte - 088 75 555 55
Isala Kliniecken Zwolle
Zwolle, Netherlands
Status: Not yet recruiting
Contact: Kooy M. van Marwijk - (038) 424 50 00
ICO Badalona
Badalona, Spain
Status: Recruiting
Contact: Susana Vives - 93 497 84 17 - uacbad@iconcologia.net
Hospital del Mar
Barcelona, Spain
Status: Recruiting
Contact: Carmen de Pedro Olive - 932 48 30 00
Hospital Universitario de Salamanca Servicio de Hematologia
Salamanca, Spain
Status: Recruiting
Contact: Maria Belén Vidriales - 0034-923-291384 - hemasecre@usal.es
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Status: Recruiting
Contact: Pau Montesinos - +34 961 244 000
Northwick Park Hospital
Harrow, England, United Kingdom
Status: Not yet recruiting
Contact: Sunder Chita - 020 8869 5829 - sunderchita@nhs.net
Royal Liverpool University Hospital, Dept of Cellular and Molecular Physiology, Molecular and Clinical Cancer Medicine
Liverpool, Lancashire, United Kingdom
Status: Recruiting
Contact: E. Richard Clark, MD PhD - 0151 706 4860
University Hospital Wales
Cardiff, Wales, United Kingdom
Status: Not yet recruiting
Contact: Sarah James - Sarah.james2@wales.nhs.uk
Hull and East Yorkshire Hospitals NHS Trust Queens Centre for Oncology and Haematology
Hull, Yorkshire, United Kingdom
Status: Recruiting
Contact: Sahra Ali, MD - 01482 875875
Ninewells Hospital and Medical School NHS Tayside
Dundee, United Kingdom
Status: Recruiting
Contact: Sudhir Tauro - 01382 660111
Plymouth Hospitals NHS Trust/Derriford Hospital
Plymouth, United Kingdom
Status: Recruiting
Contact: Patrick Medd - 0845 155 8155
Start Date
March 2014
Completion Date
September 2016
Sponsors
Karyopharm Therapeutics, Inc
Source
Karyopharm Therapeutics, Inc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page