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Selinexor (combination therapy) for Diffuse Large B-Cell Lymphoma (DLBCL)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diffuse Large B-Cell Lymphoma (DLBCL)Selinexor (combination therapy) - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new combination cancer treatment of selinexor and R-GDP, to see if it is more effective and has fewer side effects than the standard R-GDP treatment.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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RiTUXimab Injection
1
R/R DLBCL
1
EZM0414

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: From date of initial randomization until death (maximum of 5 years from randomization)

Day 28
Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014
Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Modified Lugano Criteria
Phase 3: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014
Phase 3: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Modified Lugano Criteria
Year 5
Phase 2: Progression-free Survival (PFS): Based on Lugano Criteria 2014
Phase 2: Progression-free Survival (PFS): Based on Modified Lugano Criteria
Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014
Phase 3: Progression-free Survival (PFS): Based on Modified Lugano Criteria
Year 5
Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014
Phase 3: Overall Response Rate (ORR): Based on Lugano Criteria 2014
Year 5
Phase 2: Overall Survival (OS)
Phase 3: Overall Survival (OS)
Year 5
Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014
Phase 3: Duration of Response (DOR): Based on Lugano Criteria 2014
Year 5
Phase 2: Number of Patients with Adverse Events (AEs)
Phase 3: Number of Patients with Adverse Events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
RiTUXimab Injection
1
R/R DLBCL
1
EZM0414

Trial Design

6 Treatment Groups

Phase 2: R-GDP
1 of 6
Phase 2: Selinexor 60 mg + R-GDP
1 of 6
Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
1 of 6
Phase 2: Selinexor 40 mg + R-GDP
1 of 6
Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
1 of 6
Phase 3: Placebo + R-GDP followed by Placebo
1 of 6

Active Control

Experimental Treatment

Non-Treatment Group

501 Total Participants · 6 Treatment Groups

Primary Treatment: Selinexor (combination therapy) · Has Placebo Group · Phase 2 & 3

Phase 2: Selinexor 60 mg + R-GDPExperimental Group · 6 Interventions: Selinexor (combination therapy), Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy), Selinexor (continuous therapy) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mgExperimental Group · 6 Interventions: Selinexor (combination therapy), Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy), Selinexor (continuous therapy) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Phase 2: Selinexor 40 mg + R-GDPExperimental Group · 6 Interventions: Selinexor (combination therapy), Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy), Selinexor (continuous therapy) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Phase 3: Selinexor (Selected Dose) + R-GDP followed by PlaceboExperimental Group · 6 Interventions: Placebo matching for Selinexor (continuous therapy), Selinexor (combination therapy), Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Phase 3: Placebo + R-GDP followed by PlaceboPlaceboComparator Group · 6 Interventions: Placebo matching for Selinexor (continuous therapy), Placebo matching for Selinexor (combination therapy), Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Phase 2: R-GDPActiveComparator Group · 4 Interventions: Rituximab (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Gemcitabine (combination therapy) · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of initial randomization until death (maximum of 5 years from randomization)

Who is running the clinical trial?

Karyopharm Therapeutics IncLead Sponsor
84 Previous Clinical Trials
7,642 Total Patients Enrolled
1 Trials studying Diffuse Large B-Cell Lymphoma (DLBCL)
22 Patients Enrolled for Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
PET is used to detect cancer if there is a measurable disease with at least 1 node that is greater than 1.5 centimeters or 1 extranodal lesion that is greater than 1 centimeter.
The patient's platelet count must be at least 100,000 per liter without a platelet transfusion less than 14 days prior to the first day of the patient's first cycle.
Hemoglobin ≥8.5 g/dL without red blood cell transfusion in the past 14 days.
ANC of at least 1*10^9 per liter.
I have received at least 1 but no more than 2 prior lines of systemic therapy for the treatment of DLBCL.
If cancer is found to have returned or if it is not responding to other treatments, salvage chemoimmunotherapy followed by stem cell transplantation may be considered as a possible treatment option.
"Maintenance therapy will not be counted as a separate line of systemic therapy," said the study authors.
ineligible for HSCT or CAR-T cell therapy based on the judgement of their doctor; patients without active disease are allowed on the study, but up to 10% of all patients enrolled in each phase must have active disease
The study is for patients with DLBCL or lymphoma that has transformed from a previously diagnosed indolent lymphoma
Radiation therapy that is used to cure localized DLBCL will not be counted as 1 line of systemic therapy.
References

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