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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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My blood cell counts are within a healthy range.
Select...
I have a type of lymphoma that has not been treated yet.
Select...
I have a lymphoma lesion that shows up on PET/CT scans.
Select...
My blood test shows I am at high risk due to cancer DNA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
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 moreSide effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
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%
Cytomegalovirus infection reactivation
6%
Rash
6%
Upper respiratory tract infection
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
2,434 Previous Clinical Trials
1,091,352 Total Patients Enrolled
117 Trials studying Lymphoma
25,686 Patients Enrolled for Lymphoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,996 Total Patients Enrolled
95 Trials studying Lymphoma
24,099 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.My blood cell counts are within a healthy range.I have had a solid organ or bone marrow transplant.I have received treatment for a slow-growing type of lymphoma.I am allergic or cannot take part of the R-CHOP chemotherapy.I have a type of lymphoma that has not been treated yet.I have been diagnosed with a specific type of B-cell lymphoma.I have had treatment for DLBCL or HGBCL before.I have a lymphoma lesion that shows up on PET/CT scans.My blood test shows I am at high risk due to cancer DNA.I have provided blood samples for cancer DNA tests before starting my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Glofitamab + R-CHOP Immunochemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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