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Alkylating agents

Glofitamab + R-CHOP for Diffuse Large B-Cell Lymphoma

Phase 2
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
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate hematopoietic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug combo for treating aggressive lymphoma in people with a high risk form of the disease.

Who is the study for?
This trial is for patients with untreated CD20-positive Diffuse Large B-Cell Lymphoma (DLBCL) who are at high risk based on circulating tumor DNA. They should have a good performance status, measurable lymphoma lesions, normal heart function, and adequate blood cell counts. Pregnant or breastfeeding individuals and those with certain other lymphomas or prior treatments are excluded.Check my eligibility
What is being tested?
The study tests the combination of Glofitamab and Rituximab with CHOP chemotherapy in high-risk DLBCL patients as a first treatment. It's an open-label Phase II trial to assess safety, effectiveness, and how the body processes these drugs.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of the drugs, impact on organ functions due to chemotherapy agents like Doxorubicin and Cyclophosphamide, increased risk of infections from immune suppression by Prednisone, nerve damage from Vincristine use, among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 blood cell counts are within a healthy range.
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I have a type of lymphoma that has not been treated yet.
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I have a lymphoma lesion that shows up on PET/CT scans.
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My blood test shows I am at high risk due to cancer DNA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
End of Treatment Complete Response (EOT CR) Rate
Secondary outcome measures
Maximum Concentration (Cmax) of Glofitamab
Overall Response Rate (ORR) at the EOT
Overall Survival (OS)
+4 more

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608
41%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Rash
6%
Upper respiratory tract infection
6%
Cytomegalovirus infection reactivation
6%
Thrombosis
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx

Trial Design

1Treatment groups
Experimental Treatment
Group I: Glofitamab + R-CHOP ImmunochemotherapyExperimental Treatment7 Interventions
Participants will receive step-up doses of glofitamab, starting on Day 8 of Cycle 3 (2.5 mg), Day 15 of Cycle 3 (10 mg), then 30 mg glofitamab will be given every three weeks (Q3W) onwards, on Day 8 of Cycles 4-6 and on Day 1 of Cycles 7-10. (cycle length = 21 days) Participants will receive rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone will be administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Tocilizumab
2012
Completed Phase 4
~1840
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,183 Total Patients Enrolled
117 Trials studying Lymphoma
25,686 Patients Enrolled for Lymphoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,900 Total Patients Enrolled
95 Trials studying Lymphoma
24,099 Patients Enrolled for Lymphoma

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04980222 — Phase 2
Lymphoma Research Study Groups: Glofitamab + R-CHOP Immunochemotherapy
Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04980222 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980222 — Phase 2

Frequently Asked Questions

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

In what applications is Glofitamab regularly employed?

"Glofitamab is an effective therapeutic agent for treating lung cancers, small cell lung cancer (sclc), and thyroiditis."

Answered by AI

Are there any potential risks associated with Glofitamab treatment?

"Taking into account the Phase 2 trial status of Glofitamab, our team at Power has calculated a safety rating of 2. This indicates that there is some empirical data support its security, but no research exists implying efficacy."

Answered by AI

Is the research project currently available for enrollment?

"As reported on clinicaltrials.gov, this research is currently recruiting participants. This trial was initially made public on March 22nd 2022 and has been updated most recently on November 16th 2022."

Answered by AI

Are there numerous sites in America where this clinical research is being conducted?

"Currently, 11 medical centres are recruiting for this trial, with sites located in Portland, Duarte and Iowa City. Additionally, there is 8 other locations involved in the study."

Answered by AI

What other experiments have been conducted with Glofitamab as a primary component?

"As of the present moment, 1486 active trial studies are being conducted with Glofitamab. Out of these trials, 317 have progressed to Phase 3 and 52918 locations worldwide are conducting research for this drug. Bethesda, Maryland has a particularly large concentration of study sites related to Glofitamab."

Answered by AI

How many individuals are involved in the ongoing research project?

"In order to commence the trial, 40 participants that meet the conditions for inclusion must be sourced. The sponsor of this initiative is Hoffmann-La Roche and it will be executed from Kaiser Permanente - Portland in Oregon and City of Hope Comprehensive Cancer Center in California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma
2022. "A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04980222.
~14 spots leftby Jun 2025
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