A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Summary

The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram \[mg\] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.

Conditions

• Relapsed/Refractory Diffuse Large B-cell Lymphoma

Interventions

DRUG

Selinexor (combination therapy)

Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

DRUG

Selinexor (combination therapy)

Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

DRUG

Selinexor (combination therapy)

Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

DRUG

Placebo matching for Selinexor (combination therapy)

Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral

DRUG

Rituximab (combination therapy)

Dose: 375 milligram per meter square (mg/m\^2) on Day 1; Route of administration: intravenous (IV)

DRUG

Rituximab (combination therapy)

Dose: 375 mg/m\^2 on Day 1; Route of administration: IV

DRUG

Gemcitabine (combination therapy)

Dose: 1000 mg/m\^2 on Days 1 and 8; Route of administration: IV

DRUG

Dexamethasone (combination therapy)

Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV

DRUG

Cisplatin (combination therapy)

Dose: 75 mg/m\^2 on Day 1; Route of administration: IV

DRUG

Selinexor (continuous therapy)

Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral

DRUG

Placebo matching for Selinexor (continuous therapy)

Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral

Sponsors & Collaborators

• Karyopharm Therapeutics Inc

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-03

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States
• China
• Israel
• Italy
• Poland
• Spain

Study Locations