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Alkylating agents

Glofitamab Combo vs Rituximab Combo for Diffuse Large B-Cell Lymphoma

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has recurred ≥6 months after completion of the last line of therapy; Refractory = disease that either progressed during the last line of therapy or progressed within 6 months (<6 months) of the last line of prior therapy
At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different combinations of drugs for treating patients with relapsed or refractory diffuse large B cell lymphoma.

Who is the study for?
This trial is for adults with relapsed/refractory diffuse large B-cell lymphoma who have had at least one prior systemic therapy and are not candidates for stem cell transplant. Participants must have measurable disease, be in stable condition (ECOG 0-2), have adequate organ function, and a recent negative COVID-19 test.Check my eligibility
What is being tested?
The study compares the effectiveness of two treatments: Glofitamab combined with Gemcitabine + Oxaliplatin versus Rituximab with the same chemotherapy drugs. It aims to determine which combination is more effective for patients who haven't responded well to previous therapies.See study design
What are the potential side effects?
Potential side effects include allergic reactions to treatment components, nerve damage (peripheral neuropathy), infections due to weakened immune systems, and general side effects from chemotherapy like nausea, fatigue, or hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease came back or didn't respond to treatment within 6 months of my last therapy.
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I have a tumor that can be measured on a CT scan.
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My diagnosis is diffuse large B-cell lymphoma.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS), defined as the time from randomization to date of death from any cause
Secondary outcome measures
CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator
Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC
Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first
+9 more

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608
83%
Diarrhoea
67%
Fatigue
67%
Nausea
67%
Hypomagnesaemia
67%
Hypophosphataemia
50%
Anaemia
50%
Constipation
50%
Urinary tract infection
50%
Peripheral sensory neuropathy
33%
Thrombocytopenia
33%
Oedema peripheral
33%
Contusion
33%
Candida infection
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Hypokalaemia
33%
Thrombophlebitis
33%
Fall
17%
Oral candidiasis
17%
Asthenia
17%
Pyrexia
17%
Hepatic cirrhosis
17%
Cytokine release syndrome
17%
Blepharitis
17%
Eye pain
17%
Gastric ulcer
17%
Neutropenia
17%
Tachycardia
17%
Dysphagia
17%
Clostridium difficile infection
17%
Subdural haematoma
17%
Thermal burn
17%
Immune effector cell-associated neurotoxicity syndrome
17%
Decreased appetite
17%
Hypercalcaemia
17%
Hypocalcaemia
17%
Iron deficiency
17%
Back pain
17%
Headache
17%
Neuropathy peripheral
17%
Pruritus
17%
Dysuria
17%
Prostatomegaly
17%
Vaginal discharge
17%
Cough
17%
Dyspnoea
17%
Dyspnoea exertional
17%
Hiccups
17%
Dermatitis
17%
Exfoliative rash
17%
Skin exfoliation
17%
Flushing
17%
Orthostatic hypotension
17%
Superficial vein thrombosis
17%
Oesophageal ulcer
17%
Hypoglycaemia
17%
Rash
17%
Rash maculo-papular
17%
Hypertension
17%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Mosun-GemOx
Arm A: Glofit-GemOx

Trial Design

2Treatment groups
Experimental Treatment
Group I: R-GemOxExperimental Treatment3 Interventions
Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.
Group II: Glofit-GemOxExperimental Treatment5 Interventions
Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Rituxumab
2019
Completed Phase 2
~120
Gemcitabine
2017
Completed Phase 3
~2070
Obinutuzumab
2015
Completed Phase 3
~3250
Oxaliplatin
2011
Completed Phase 4
~2560
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,881 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,321 Total Patients Enrolled

Media Library

Gemcitabine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04408638 — Phase 3
Diffuse Large B-Cell Lymphoma Research Study Groups: R-GemOx, Glofit-GemOx
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04408638 — Phase 3
Gemcitabine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04408638 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for more participants in this clinical trial?

"Yes, the information on clinicaltrials.gov confirms that this trial is currently looking for patients. The trial was originally posted on February 23rd, 2021 and was most recently edited on October 11th, 2022. The trial is searching for 270 patients at 12 locations."

Answered by AI

Does Glofitamab have any negative side effects?

"Glofitamab's safety was evaluated by our team at Power, and it received a score of 3. A Phase 3 trial design was chosen for this medication, which is the highest level of support for efficacy and safety."

Answered by AI

What are the conditions that Glofitamab has been most effective in ameliorating?

"small cell lung cancer (sclc) is most commonly treated with Glofitamab. Glofitamab can also be useful for treating other conditions such as systemic juvenile idiopathic arthritis (sjia), head and neck carcinoma, and cervical cancers."

Answered by AI

With what other therapies has Glofitamab been compared in scientific trials?

"Currently, there are 920 ongoing clinical trials studying Glofitamab with 271 of those in Phase 3. The majority of these Glofitamab trials are based in Guangzhou, Guangdong; however, there are a total of 43355 locations worldwide where Glofitamab trials are taking place."

Answered by AI

How many different people are being helped by this clinical trial?

"Yes, up-to-date information on clinicaltrials.gov reveals that this study is still actively enrolling patients. The trial was originally posted on February 23rd, 2021 and was last updated on October 11th, 2022. The trial is looking for a total of 270 participants, to be recruited from 12 different sites."

Answered by AI
~66 spots leftby Apr 2025