Trial Outcomes & Findings for 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 (NCT NCT04980222)
NCT ID: NCT04980222
Last Updated: 2026-08-18
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to approximately 24 months
Results posted on
2026-08-18
Participant Flow
Participant milestones
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
Overall Study
Study Ongoing
|
41
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
n=45 Participants
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
Age, Continuous
|
64.0 Years
n=298 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=298 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=298 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=298 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=298 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=298 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 monthsOutcome measures
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
n=45 Participants
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
End of Treatment Complete Response (EOT CR) Rate
|
73.3 Percentage of participants
Interval 58.06 to 85.4
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 days after the final dose of study treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At pre-defined intervals up to approximately 10 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At pre-defined intervals up to approximately 10 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At pre-defined intervals up to approximately 10 monthsOutcome measures
Outcome data not reported
Adverse Events
Glofitamab + R-CHOP Immunochemotherapy
Serious events: 20 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
n=45 participants at risk
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Gastrointestinal disorders
Jejunal perforation
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
General disorders and administration site conditions
Pyrexia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Immune system disorders
Cytokine release syndrome
|
20.0%
9/45 • Number of events 11 • Approximately 43 months
|
|
Infections and infestations
Infection
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Infections and infestations
Intervertebral discitis
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Infections and infestations
Respiratory tract infection
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • Approximately 43 months
|
Other adverse events
| Measure |
Glofitamab + R-CHOP Immunochemotherapy
n=45 participants at risk
Participants received 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 received rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone were administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
6/45 • Number of events 9 • Approximately 43 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
11/45 • Number of events 13 • Approximately 43 months
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Number of events 4 • Approximately 43 months
|
|
General disorders and administration site conditions
Asthenia
|
11.1%
5/45 • Number of events 5 • Approximately 43 months
|
|
General disorders and administration site conditions
Chills
|
8.9%
4/45 • Number of events 5 • Approximately 43 months
|
|
General disorders and administration site conditions
Fatigue
|
13.3%
6/45 • Number of events 6 • Approximately 43 months
|
|
General disorders and administration site conditions
Pyrexia
|
13.3%
6/45 • Number of events 6 • Approximately 43 months
|
|
Infections and infestations
COVID-19
|
17.8%
8/45 • Number of events 11 • Approximately 43 months
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
5/45 • Number of events 6 • Approximately 43 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
3/45 • Number of events 7 • Approximately 43 months
|
|
Investigations
Lymphocyte count decreased
|
6.7%
3/45 • Number of events 12 • Approximately 43 months
|
|
Investigations
Neutrophil count decreased
|
20.0%
9/45 • Number of events 15 • Approximately 43 months
|
|
Investigations
Platelet count decreased
|
22.2%
10/45 • Number of events 18 • Approximately 43 months
|
|
Investigations
Weight decreased
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Investigations
White blood cell count decreased
|
8.9%
4/45 • Number of events 8 • Approximately 43 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.9%
4/45 • Number of events 4 • Approximately 43 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Nervous system disorders
Neuropathy peripheral
|
13.3%
6/45 • Number of events 6 • Approximately 43 months
|
|
Nervous system disorders
Polyneuropathy
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45 • Number of events 6 • Approximately 43 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
3/45 • Number of events 3 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
9/45 • Number of events 10 • Approximately 43 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.6%
16/45 • Number of events 35 • Approximately 43 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER