RECRUITING

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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Conditions

Diffuse Large B-cell LymphomaDLBCLKaryopharmKPT-330selinexor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

Official Title

A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Quick Facts

Study Start:2014-11
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02227251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
  2. * Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
  3. * Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is \>1.0. Lymph nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.
  1. * For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \<60 days or \<14 weeks prior to Cycle 1 Day 1.
  2. * Known central nervous system lymphoma or meningeal involvement.
  3. * DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.
  4. * Unstable cardiovascular function:
  5. * Participants with a BSA \<1.4 m\^2 as calculated per Dubois 1916 or Mosteller 1987.
  6. * Any of the following laboratory abnormalities:
  7. * Participants who have been committed to an institution by official or judicial order.
  8. * Participants with dependency on the Sponsor, Investigator or study site.

Contacts and Locations

Study Contact

Karyopharm Medical Information
CONTACT
(888) 209-9326
clinicaltrials@karyopharm.com

Study Locations (Sites)

UACC Arizona
Tucson, Arizona, 85704
United States
University of California San Francisco
San Francisco, California
United States
University of California Los Angeles (UCLA)
Santa Monica, California, 90404
United States
Boca Raton Cancer Research Medical Center
Plantation, Florida
United States
University of Chicago
Chicago, Illinois, 60637
United States
Robert H. Lurie Comprehensive Cancer Center/Northwestern University
Chicago, Illinois
United States
Norton Cancer Institute
Louisville, Kentucky, 40241
United States
Dana Farber Cancer Institute
Boston, Massachusetts
United States
Tufts Medical Center
Boston, Massachusetts
United States
Lahey Clinic
Burlington, Massachusetts
United States
University of Massachusetts Medical School
Worcester, Massachusetts
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey
United States
Clinical Research Alliance
Lake Success, New York
United States
New York Presbyterian Hospital/ Cornell Medical College
New York, New York, 10065
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio
United States
University of Oklahoma
Oklahoma City, Oklahoma
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
MD Anderson
Houston, Texas, 77030
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Virginia Mason Hospital & Medical Center
Seattle, Washington
United States

Collaborators and Investigators

Sponsor: Karyopharm Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-11
Study Completion Date2027-11

Study Record Updates

Study Start Date2014-11
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Diffuse large B-cell Lymphoma
  • DLBCL
  • Karyopharm
  • KPT-330
  • selinexor

Additional Relevant MeSH Terms

  • Diffuse Large B-cell Lymphoma