Clinical trialPhase 3Lymphoma

Glofitamab plus gemcitabine and oxaliplatin for relapsed/refractory DLBCL: 3-year follow-up of STARGLO.

Blood Adv · 2026The number of patients is not given in the abstract of this report (per the primary STARGLO report: 274 patients, 183 in the Glofit-GemOx group and 91 in the R-GemOx group)

Abramson JS, Townsend W, Fox CP, et al. Blood Adv. 2026. 10:5367-5377

Study type: Clinical trial
Study name: STARGLO
Phase: Phase 3
Design: Randomised phase 3 trial; long-term follow-up report (median overall survival follow-up 35.1 months, data cut-off 1 May 2025)
Sample size: The number of patients is not given in the abstract of this report (per the primary STARGLO report: 274 patients, 183 in the Glofit-GemOx group and 91 in the R-GemOx group)
Source: Blood Adv · 2026
Trial registration: NCT04408638

In plain words

This report gives the results of about three years of follow-up of patients in the STARGLO study. Patients with diffuse large B-cell lymphoma whose disease had come back or had not responded to treatment, and who could not have a bone marrow transplant, received either the drug glofitamab (an antibody that steers the body's immune cells towards the lymphoma cells) with GemOx chemotherapy or rituximab with the same chemotherapy. The glofitamab group lived on average almost twice as long, and their disease grew later. This benefit was also seen in older patients and was greater in those treated at their first relapse. No new or unexpected side effects were seen during this time.

Key results

25.5 vs 12.5 months

Median overall survival

HR 0.60 (95% CI 0.4 to 0.8); median follow-up 35.1 months

14.4 vs 3.3 months

Median progression-free survival

HR 0.41 (95% CI 0.3 to 0.6)

58.5% vs 25.3%

Complete response rate

Glofit-GemOx vs R-GemOx

54.6% in the second line vs 33.2% in the third or later line

3-year overall survival with Glofit-GemOx by line of therapy

95% CI 45.2 to 64.0 and 21.2 to 45.3

46.1% vs 16.5%

36-month overall survival in the second line, primary refractory disease or early treatment failure

95% CI 35.2 to 56.9 vs 3.4 to 29.6

Drugs in this study:Gemcitabine (Gemzar)Oxaliplatin (Eloxatin)Rituximab (Rituxan/MabThera)

Dose and schedule cards

Glofitamab + GemOx (STARGLO trial)

Relapsed or refractory DLBCL after one or more lines of therapy in patients who are not transplant candidatesCycle length: Every 21 daysOn the page “Lymphoma” · Treatment regimens and dosing: relapsed or refractory DLBCL, transplant-ineligible and later lines

Relapsed or refractory DLBCL after one or more lines of therapy in patients who are not transplant candidates

Drug	Dose	Route	Schedule
Pretreatment
Obinutuzumab	Single dose	IV	7 days before the first glofitamab dose
Cycles 1–8
Glofitamab	Step-up dosing to 30 mg	IV	Per protocol
Gemcitabine	1000 mg/m²	IV	Each cycle (day per protocol)
Oxaliplatin	100 mg/m²	IV	Each cycle (day per protocol)
Cycles 9–12
Glofitamab	30 mg	IV	Day 1

Cycle length: Every 21 days
Duration: 8 cycles of glofitamab + GemOx followed by 4 cycles of single-agent glofitamab

Doses from the abstract of the STARGLO trial and obinutuzumab pretreatment from the trial registration; the exact days of step-up dosing and GemOx are given in the full text of the article. The obinutuzumab pretreatment dose in the glofitamab label is 1000 mg. Premedication, tumour lysis syndrome prophylaxis and cytokine release syndrome monitoring are the same as for single-agent glofitamab.

On the page “Lymphoma” · Treatment regimens and dosing: relapsed or refractory DLBCL, transplant-ineligible and later lines

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Glofit-GemOx

Pretreatment with a single dose of IV obinutuzumab 7 days before the first glofitamab dose; then IV glofitamab with step-up dosing to 30 mg plus IV gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m², in 21-day cycles, 8 cycles in total, followed by 4 cycles of glofitamab alone (up to 12 cycles of glofitamab). Tocilizumab as needed for cytokine release syndrome.

2R-GemOx

Rituximab 375 mg/m² IV on day 1 with gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m², in 21-day cycles, 8 cycles in total.

Source of the regimen details: Abstract of the primary STARGLO report (Lancet 2024) and ClinicalTrials.gov NCT04408638; exact step-up dosing days in the full text

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were not candidates for autologous stem cell transplantation (ASCT); in second or later lines of therapy.

Endpoints

In this follow-up report: overall survival, progression-free survival, complete response rate and safety, including in clinically important subgroups (line of therapy, primary refractory disease or early treatment failure, age).

Safety and side effects

With longer follow-up, no new safety signals were identified. Adverse event details in the full text.

Clinical significance and place in guidelines

This 3-year follow-up confirms that the superiority of Glofit-GemOx over R-GemOx in overall survival and progression-free survival in patients with relapsed or refractory DLBCL who are not candidates for autologous transplantation is durable, especially in the second line and even in patients with primary refractory disease or early treatment failure. These data strengthen the place of Glofit-GemOx as a fixed-duration option for these patients; it was not compared directly with CAR T therapy in this study.

Limitations

The comparator (R-GemOx) has poor outcomes and is not considered a strong control. Subgroup analyses (line of therapy, age, primary refractory disease) are exploratory and confidence intervals are wide in some subgroups. The abstract does not give details of patient numbers and adverse events.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.