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

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Diffuse Large B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Tucson

UACC Arizona, Tucson, Arizona, United States, 85704

San Francisco

University of California San Francisco, San Francisco, California, United States,

Santa Monica

University of California Los Angeles (UCLA), Santa Monica, California, United States, 90404

Plantation

Boca Raton Cancer Research Medical Center, Plantation, Florida, United States,

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Chicago

Robert H. Lurie Comprehensive Cancer Center/Northwestern University, Chicago, Illinois, United States,

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40241

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States,

Boston

Tufts Medical Center, Boston, Massachusetts, United States,

Burlington

Lahey Clinic, Burlington, Massachusetts, United States,

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
  • * 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.
  • * 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.
  • * Known central nervous system lymphoma or meningeal involvement.
  • * DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.
  • * Unstable cardiovascular function:
  • * Participants with a BSA \<1.4 m\^2 as calculated per Dubois 1916 or Mosteller 1987.
  • * Any of the following laboratory abnormalities:
  • * Participants who have been committed to an institution by official or judicial order.
  • * Participants with dependency on the Sponsor, Investigator or study site.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Karyopharm Therapeutics Inc,

Study Record Dates

2027-11