Study on Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or Without Selinexor for Patients with Relapsed or Hard-to-Treat Diffuse Large B-cell Lymphoma
Sponsor: Karyopharm Therapeutics Inc
ClinicalTrials ID:NCT04442022
This clinical trial is testing a new treatment combination for patients with Diffuse Large B-cell Lymphoma (DLBCL) that has returned or is not responding to treatment. The study will compare the effects of adding the drug selinexor to the standard R-GDP treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if adding selinexor to the standard R-GDP treatment can help patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) who are not eligible for stem cell or CAR-T cell therapy. The trial will have two phases. In Phase 2, different doses of selinexor will be tested with R-GDP to see which is most effective. In Phase 3, the best dose from Phase 2 will be compared to the standard R-GDP treatment to see if it works better. Patients who respond well to the treatment will continue with selinexor or a placebo alone.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) or DLBCL that has changed from a slower-growing lymphoma.
- Have received 1 to 3 previous treatments for DLBCL that did not work or the cancer came back.
- Have a PET scan showing at least one tumor that can be measured.
- Not planning to have stem cell or CAR-T cell therapy.
- Have good bone marrow, liver, and kidney function based on blood tests.
- Be in good general health with an ECOG performance status of 0 to 2.
- Have a life expectancy of more than 3 months.
- Agree to use effective birth control during the study and for 12 months after the last treatment.
- Women must have a negative pregnancy test before starting the study.
- Men must agree not to donate sperm during the study and for 12 months after the last treatment.
Exclusion Criteria
- Have certain types of lymphoma not included in the study.
- Have been treated with selinexor or similar drugs before.
- Have allergies to any drugs in the study treatment.
- Have active cancer in the brain or spinal cord.
- Have had other cancer treatments within 21 days before starting the study.
- Have not recovered from side effects of previous cancer treatments.
- Have had major surgery within 14 days before starting the study.
- Have had recent stem cell or CAR-T cell therapy.
- Have severe nerve damage.
- Have serious health conditions that could affect safety or study participation.
- Have uncontrolled infections or certain viral infections.
- Cannot swallow pills or have digestive issues affecting drug absorption.
- Are pregnant or breastfeeding.
- Cannot or do not want to sign the consent form.
- Are significantly underweight according to the study doctor.
- Have received a live vaccine within 28 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | 85224 | Chandler | Arizona |
| Arizona Oncology Associates | 85711 | Tucson | Arizona |
| The Oncology Institute (TOI) Clinical Research | 90703 | Cerritos | California |
| Investigative Clinical Research of Indiana, LLC | 46260 | Indianapolis | Indiana |
| Norton Cancer Institute, St. Matthews | 40207 | Louisville | Kentucky |
| Tulane Cancer Center | 70112 | New Orleans | Louisiana |
| University of Maryland Greenebaum Comprehensive Cancer Center | 21201 | Baltimore | Maryland |
| Comprehensive Cancer Centers of Nevada - Town Center | 89169 | Las Vegas | Nevada |
| New Mexico Cancer Care Alliance | 87106 | Albuquerque | New Mexico |
| Stony Brook | 11794 | Stony Brook | New York |
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