Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation

Stopped early · Phase 2

Conditions studied: Richter's Transformation

In brief

This is a multi-center, phase 2, single arm, open-label study of oral selinexor monotherapy in patients with Richter's Transformation, arising in the setting of prior chronic lymphocytic leukemia (CLL), after at least one chemo-immunotherapy regimen for CLL.

Key facts

Study ID

NCT02138786

Run by

Karyopharm Therapeutics Inc

People needed

27

Starts

2014-11-14

Expected to finish

2016-08-31

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Richter's Transformation, arising in the setting of prior CLL, documented by histologically confirmed lymphoma, including large B-cell and immunoblastic variants.
• All patients must have received at least one prior regimen for CLL, including cytotoxic chemotherapy, anti-CD20 monoclonal antibodies, a BTK inhibitor, or a PI3K inhibitor. Patients may have received high dose chemotherapy/autologous stem cell transplant (HDT/ASCT) or allogeneic hematopoietic stem cell transplant (allo SCT).
• One or more measurable (> 1.5 cm in longest dimension) disease sites on CT (preferably PET/CT) or, if CT is contraindicated, MRI (preferably PET/MRI) scans.
• Objective documented evidence of disease progression at study entry
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2

You may not qualify if…

• Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1, except ibrutinib which may be continued until one day prior to initiation of selinexor; radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Patients must have recovered to Grade ≤ 1 from clinically significant adverse effects.
• Prolymphocytic transformation
• Less than 1 month since completion of autologous stem cell transplantation or less than 3 months since completion of allogeneic stem cell transplantation
• Major surgery within 4 weeks of C1D1
• Impairment of GI function or GI disease that could interfere with the absorption of selinexor, including obstructed GI tract and uncontrolled vomiting or diarrhea.
• Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant (e.g., mirtazapine or olanzapine) and a peripherally acting appetite stimulant (e.g., low dose glucocorticoids or megesterol acetate).

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California-Los Angeles — Santa Monica, California, United States
• Winship Cancer Institute / Emory University — Atlanta, Georgia, United States
• Weill Cornell Medical College — New York, New York, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• University of Ulm — Ulm, Baden-Wurttemberg, Germany
• University Hospital of Cologne — Cologne, Germany
• Malopolskie Centrum Medyczne — Krakow, Poland
• Copernicus Memorial Hospital, Department of Hematology — Lodz, Poland
• Maria Skłodowska-Curie Institue of Oncology — Warsaw, Poland
• Instituto Clinico Navarra, Pamplona — Pamplona, Navarre, Spain
• Institut Català d'Oncologia Av. — Barcelona, Spain
• Hospital Vall Hebron — Barcelona, Spain
• The Royal Marsden NHS Foundation Trust — Sutton, Surrey, United Kingdom
• Churchill Hospital: Cancer and Haematology Centre — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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