Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04442022 · ClinicalTrials.gov registry record · Phase 2
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study of Relapsed/Refractory Diffuse Large B-cell Lymphoma, sponsored by Karyopharm Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 501
- Enrollment target
- 20
- Study locations
NCT04442022 is a Phase 2 study of Relapsed/Refractory Diffuse Large B-cell Lymphoma that is actively recruiting participants, run by Karyopharm Therapeutics. The registered enrollment target is 501 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT04442022, a Phase 2 study of Relapsed/Refractory Diffuse Large B-cell Lymphoma, is actively recruiting participants, sponsored by Karyopharm Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 501 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Selinexor (combination therapy)
- DRUG Placebo matching for Selinexor (combination therapy)
- DRUG Rituximab (combination therapy)
Study Locations (20)
Texas
- Texas Oncology - Medical City Dallas - Dallas
- Texas Oncology - Presbyterian Dallas Cancer Center - Dallas
- Texas Oncology - Sammons - Dallas
- Texas Oncology - Fort Worth - Fort Worth
- Texas Oncology - Plano East - Plano
- Texas Oncology - Tyler - Tyler
- The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center - Tyler
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler
- Arizona Oncology Associates - Tucson
California
- The Oncology Institute (TOI) Clinical Research - Cerritos
Indiana
- Investigative Clinical Research of Indiana, LLC - Indianapolis
Kentucky
- Norton Cancer Institute, St. Matthews - Louisville
Louisiana
- Tulane Cancer Center - New Orleans
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Nevada
- Comprehensive Cancer Centers of Nevada - Town Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04442022
The ClinicalTrials.gov registry entry for NCT04442022 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed/Refractory Diffuse Large B-cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Selinexor (combination therapy) is the first listed.
NCT04442022 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04442022 about?
NCT04442022 is a clinical study titled "A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma". 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 o...
What is the current status of trial NCT04442022?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 501 participants. The study started on 2020-09-03. Estimated completion is 2025-12.
What conditions does trial NCT04442022 study?
This clinical trial studies the following conditions: Relapsed/Refractory Diffuse Large B-cell Lymphoma.
What interventions are being tested in trial NCT04442022?
The interventions under investigation include: Selinexor (combination therapy) (DRUG), Placebo matching for Selinexor (combination therapy) (DRUG), Rituximab (combination therapy) (DRUG).
Who is sponsoring clinical trial NCT04442022?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04442022 being conducted?
This trial has 20 study locations across Arizona, California, Indiana, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.