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Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicenter, Phase 1/2 Study of Selinexor in Combination With Backbone Treatments or Novel Therapies in Patients With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04607772•Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the efficacy, and safety of various combinations with selinexor in participants with RR DLBCL. The study will be conducted in two phases: Phase 1 and 2. The Phase 1 of the study will be a standard 3 + 3 dose escalation to determine the maximal tolerated dose (MTD), recommended Phase 2 dose (RP2D) for each treatment arm, and assess the dose limiting toxicities (DLTs). The Phase 2 of the study will be a dose expansion study to assess the efficacy and safety of for RP2D selected at the end of Phase 1 of the study for each treatment arm.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants greater than or equal to (≥) 18 years of age.
•2. Have pathologically confirmed relapsed/refractory (RR) DLBCL, not otherwise specified (NOS).
•3. Participants with High Grade B-cell Lymphoma (HGBL) are allowed in Phase 2 only.
•4. Prior lines of systemic therapy for the treatment of DLBCL:
•* For Arms A, B, C, E, F, G, H: Participants must have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL.
•* For Arm D (S-R-GemOx) participants must have received at least 1 but not more than 2 lines of systemic therapy.
•5. Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than (\>) 1.5 centimetres (cm) or 1 extranodal lesion with LDi \>1 cm.
•6. Adequate bone marrow function at Screening.
•7. Circulating lymphocytes less than or equal to (≤) 50 \* 109/L.
•8. Adequate liver and kidney function.
+5 more criteria

Exclusion Criteria

•1. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.
•2. Previous treatment with selinexor or other XPO1 inhibitors.
•3. Contraindication to any drug contained in the different treatment arms.
•4. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to Cycle 1 Day 1 (C1D1). Low dose steroids \<30 mg prednisone (or equivalent) and palliative radiotherapy are permitted.
•5. Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or strong CYP3A inducers ≤14 days prior to Day 1 dosing.
•6. Any AE, by Cycle 1 Day 1 (C1D1), which has not recovered to Grade ≤1 (CTCAE, v. 5.0), or returned to baseline, related to the previous DLBCL therapy, except alopecia.
•7. Major surgery \<14 days of C1D1.
•8. Autologous stem cell transplant (SCT) \<100 days or allogeneic SCT \<180 days prior to C1D1 or active graft-versus-host disease after allogeneic SCT (or cannot discontinue graft versus host disease \[GVHD\] treatment or prophylaxis).
•9. Prior chimeric antigen receptor T cell (CAR-T cell) infusion at any time (Phase 1 only); prior CAR-T cell infusion ≤120 days prior to C1D1 (Phase 2 only).
•10. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, or able to comply with the study procedures.
+9 more criteria

Locations (18)

University of Arizona

Tucson, Arizona, United States

California Cancer Associates for Research and Excellence

Encinitas, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of California Irvine

Orange, California, United States

US Oncology - Rocky Mountain Cancer Center

Aurora, Colorado, United States

Loyola University Medical Center

Maywood, Illinois, United States

Mission Cancer + Blood

Des Moines, Iowa, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Key Dates

Start Date

November 18, 2020

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 3, 2025

Conditions

Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Interventions

Selinexor

DRUG

Rituximab

DRUG

Bendamustine

DRUG

Polatuzumab Vedotin

DRUG

Ibrutinib

DRUG

Lenalidomide

DRUG

Tafasitamab

DRUG

Venetoclax

DRUG

Gemcitabine

DRUG

Oxaliplatin

DRUG

A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL

NCT04049825

Relapsed or Refractory Diffuse Large B-cell Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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