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