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Not yet recruiting NCT07669194

Glofitamab Combined With Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

— Observational Diffuse Large B-Cell Lymphoma (DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glofitamab combined with selinexor.
Who it may be relevant to
Registry conditions: Diffuse Large B-Cell Lymphoma (DLBCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Overview

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.

Interventions

  • Drug Glofitamab combined with selinexor
    Patients receive obinutuzumab 1000 mg intravenously (IV) on Day 1 of Cycle 1 to mitigate cytokine release syndrome (CRS) risk. Glofitamab is administered IV with step-up dosing at 2.5 mg on Day 8 and 10 mg on Day 15 of Cycle 1, followed by a target dose of 30 mg on Day 1 of Cycles 2 through 12. Selinexor is administered orally at 60 mg on Days 1 and 3 of each week, starting from Cycle 2 through Cycle 12. Each cycle is 21 days. The total fixed duration of treatment is 12 cycles.

Primary outcome measures

  • Complete Response Rate (CRR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
  • Duration of Complete Response (DoCR) [Time frame: Up to approximately 2 years]
  • Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]
  • Incidence and Severity of Adverse Events (AEs) [Time frame: From baseline up to 90 days after the last dose of study treatment (assessed up to approximately 2 years)]

Eligibility criteria

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 2.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT07669194 · 2026-0473

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗