OncoMatch/Clinical Trials/NCT04442022
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Is NCT04442022 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for relapsed/refractory diffuse large b-cell lymphoma.
Treatment: Selinexor (combination therapy) · Selinexor (combination therapy) · Selinexor (combination therapy) · Rituximab (combination therapy) · Rituximab (combination therapy) · Gemcitabine (combination therapy) · Dexamethasone (combination therapy) · Cisplatin (combination therapy) · Selinexor (continuous therapy) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: BCL2 rearrangement
Allowed: BCL6 rearrangement
Allowed: MYC rearrangement
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: XPO1 inhibitor (selinexor)
Previous treatment with selinexor or other XPO1 inhibitors.
Cannot have received: hematopoietic stem cell transplantation
Exception: Autologous SCT <100 days or allogeneic-SCT <180 days prior to C1D1; active GVHD after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis)
Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1; active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis)
Cannot have received: CAR-T cell therapy
Exception: CAR-T cell infusion <90 days prior to Cycle 1
CAR-T cell infusion <90 days prior to Cycle 1
Cannot have received: any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy)
Exception: prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions
Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions).
Lab requirements
Blood counts
ANC ≥1×10^9/L; Platelet count ≥100×10^9/L (without platelet transfusion <14 days prior to C1D1); Hemoglobin ≥8.5 g/dL (without red blood cell transfusion <14 days prior to C1D1); Circulating lymphocytes ≤50×10^9/L
Kidney function
Calculated creatinine clearance (CrCl) ≥30 mL/min based on Cockcroft-Gault formula
Liver function
AST or ALT ≤2.5×ULN, or ≤5×ULN in cases with known lymphoma involvement in the liver; serum total bilirubin ≤2×ULN, or ≤5×ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver
Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) ≥1×10^9/L. Platelet count ≥100×10^9/L (without platelet transfusion <14 days prior to C1D1). Hemoglobin ≥8.5 g/dL (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes ≤50×10^9/L. Adequate liver and kidney function, defined as: AST or ALT ≤2.5×ULN, or ≤5×ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin ≤2×ULN, or ≤5×ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) ≥30 mL/min based on Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers · Chandler, Arizona
- Arizona Oncology Associates · Tucson, Arizona
- The Oncology Institute (TOI) Clinical Research · Cerritos, California
- Investigative Clinical Research of Indiana, LLC · Indianapolis, Indiana
- Norton Cancer Institute, St. Matthews · Louisville, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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