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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)

NCT04607772 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Selinexor

Dose: 40 mg (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg), 80 mg (4 tablets of 20 mg)

DRUG

Rituximab

Dose: 375 mg/m\^2

DRUG

Bendamustine

Dose: 90 mg/m\^2

DRUG

Polatuzumab Vedotin

Dose: 1.8 mg/kg

DRUG

Ibrutinib

Dose: 420, 560 mg

DRUG

Lenalidomide

Dose: 20, 25 mg

DRUG

Tafasitamab

Dose: 12 mg/kg

DRUG

Venetoclax

Dose: 200, 400, 600, 800 mg

DRUG

Gemcitabine

Dose: 1000 mg/m\^2

DRUG

Oxaliplatin

Dose: 100 mg/m\^2

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607772 on ClinicalTrials.gov