Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
Assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in patients who have received at least two prior lines of systemic therapy.
Detailed Description
Currently, patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have failed at least two lines of systemic therapy have a poor prognosis, and there is a significant clinical need for new treatment options. Glofitamab and selinexor have both demonstrated clinical activity as single agents in R/R DLBCL. Because their mechanisms of action are complementary and their toxicity profiles do not overlap significantly, this combination holds the potential to further improve outcomes. Therefore, this study plans to assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of R/R DLBCL patients who have previously received at least two lines of systemic therapy. Enrolled patients will receive study treatments for up to 12 cycles, with each 21-day period being one cycle. Cycle 1 involves obinutuzumab pre-treatment and step-up dosing of glofitamab. From Cycle 2 to Cycle 12, patients will receive glofitamab in combination with oral selinexor. Interim efficacy evaluations will be conducted during the treatment. At the end of the 12 cycles or upon treatment discontinuation, a final efficacy evaluation will be conducted, followed by a long-term follow-up period.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and older at the time of informed consent.
- •Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
- •Relapsed or refractory disease, having previously received at least two lines of systemic therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
- •Presence of measurable disease.
- •Adequate hematologic, hepatic, and renal function.
- •Willingness to use effective contraception methods during the study and for a specified period after the last dose.
- •Willing and able to provide written informed consent and comply with the study protocol.
Exclusion Criteria
- •Prior treatment with any CD20/CD3 bispecific antibodies or XPO1 inhibitors.
- •Current or prior history of central nervous system (CNS) involvement by lymphoma or other significant CNS diseases.
- •Active and uncontrolled systemic infections, including known HIV infection, active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV) infection.
- •Active autoimmune diseases requiring systemic immunosuppressive therapy.
- •Clinically significant, severe, or uncontrolled cardiovascular diseases.
- •Other active invasive malignancies within the past 2 years (with exceptions for adequately treated localized cancers).
- •Recent major surgery or receipt of live attenuated vaccines within a specified timeframe prior to the study.
- •Severe gastrointestinal conditions that may significantly affect the absorption of oral medications.
- •Known severe allergic reactions to any of the study drugs or their excipients.
- •Pregnant or breastfeeding women.