A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Public ClinicalTrials.gov record NCT04442022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04442022
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 501 participants
Conditions and interventions
Interventions
- Selinexor (combination therapy) Drug
- Placebo matching for Selinexor (combination therapy) Drug
- Rituximab (combination therapy) Drug
- Gemcitabine (combination therapy) Drug
- Dexamethasone (combination therapy) Drug
- Cisplatin (combination therapy) Drug
- Selinexor (continuous therapy) Drug
- Placebo matching for Selinexor (continuous therapy) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2, 2020
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jul 1, 2026
2020 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates | Tucson | Arizona | 85711 | — |
| The Oncology Institute (TOI) Clinical Research | Cerritos | California | 90703 | — |
| Norton Cancer Institute, St. Matthews | Louisville | Kentucky | 40207 | — |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Stony Brook | Stony Brook | New York | 11794 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04442022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04442022 live on ClinicalTrials.gov.