Phase 1
Completed N=23
A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
Source: ClinicalTrials.gov NCT04313608 ↗Enrolled (actual)
23
Serious AEs
69.6%
Results posted
Mar 2024
Primary outcomePrimary: Number of Deaths Due to Adverse Events (AEs) — 1; 0 Participants
Summary
This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Deaths Due to Adverse Events (AEs) |
1; 0 | — |
| PRIMARY Number of Treatment Discontinuations Due to AE |
1; 1 | — |
| PRIMARY Proportion of Participants With Serious Adverse Events (SAEs) |
70.6; 66.7 | — |
| PRIMARY Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity |
29.4; 16.7; 11.8; 0; 5.9; 0 | — |
| SECONDARY Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs |
5.9; 16.7; 29.4; 50.0 | — |
| SECONDARY Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria |
23.5; 50.0 | — |
| SECONDARY Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria |
35.3; 50.0 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Glofitamab |
0; 0.6; 0.6; 0.5; 0.3; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2
- Histologically confirmed B-cell lymphoma, including one of the following diagnoses per the 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); HGBCL with MYC and BCL2 and/or BCL6 rearrangements; HGBCL, NOS
- R/R disease, defined as follows: Relapse: disease that has recurred following a response that lasted >/=6 months after completion of last line of therapy; Refractory: disease that progressed during therapy or progressed within 6 months ( 1 peripheral neuropathy
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to the first study treatment
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to first study treatment
- Suspected or latent tuberculosis
- Positive test results for chronic hepatitis B virus (HBV) infection
- Positive test results for hepatitis C virus (HCV) antibody
- Known HIV-seropositive status
- Known or suspected chronic active Epstein-Barr virus infection
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- History of progressive multifocal leukoencephalopathy
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
- Administration of a live, attenuated vaccine within 4 weeks prior to the first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- Prior solid organ transplantation
- Prior allogenic stem cell transplant
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks prior to the first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment, with exceptions defined by the study protocol
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of liver disease, including cirrhosis
Data sourced from ClinicalTrials.gov (NCT04313608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.