Trial · NCT04313608

A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

NCT04313608, Phase 1, Completed, Hoffmann-La Roche; results first posted 2024-03-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma. Trials, record NCT04313608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04313608

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
NCT number: NCT04313608
Status: Completed
Phases: Phase 1
Enrollment: 23 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: B-cell Lymphoma
Interventions: Glofitamab, Gemcitabine, Oxaliplatin, Mosunetuzumab, Obinutuzumab, Tocilizumab
First posted: 2020-03-18
Last updated: 2024-03-25
Results first posted: 2024-03-25

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Deaths Due to Adverse Events (AEs)	Baseline - 90 days after last dose of study treatment	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Primary	Number of Treatment Discontinuations Due to AE	Baseline - 90 days after last dose of study treatment	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Primary	Proportion of Participants With Serious Adverse Events (SAEs)	Baseline - 90 days after last dose of study treatment	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Primary	Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity	Baseline - 90 days after last dose of study treatment	Severity of CRS was determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria, in which Grade 1 as fever (≥38.0°C) with or without other symptoms; Grade 2 as fever with hypotension not requiring vasopressors and/or hypoxia requiring the use of oxygen (low-flow); and Grade 3 as fever with hypotension requiring one vasopressor with or without vasopressin and/or hypoxia requiring the use of oxygen (high-flow).
Secondary	Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Up to approximately 16 months
Secondary	Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria	Up to approximately 16 months	Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), with higher scores indicating more extensive disease.
Secondary	Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria	Up to approximately 16 months	Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), while a PR = partial metabolic response with a score of 4 or 5 on 5PS with higher scores indicating more extensive disease.
Secondary	Maximum Serum Concentration (Cmax) of Glofitamab	Cycle 1 Day 8 and Cycle 2 Day 1

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Deaths Due to Adverse Events (AEs)	Baseline - 90 days after last dose of study treatment		Participants	NUMBER
SECONDARY	Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Up to approximately 16 months		percentage of participants	NUMBER
SECONDARY	Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria	Up to approximately 16 months		percentage	NUMBER
SECONDARY	Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria	Up to approximately 16 months		Proportion expressed as percentage	NUMBER
SECONDARY	Maximum Serum Concentration (Cmax) of Glofitamab	Cycle 1 Day 8 and Cycle 2 Day 1	The pharmacokinetic population consisted of all participants that received at least one dose of glofitamab or mosunetuzumab and who had data from at least one post-dose sample.	ug/mL	MEDIAN
PRIMARY	Number of Treatment Discontinuations Due to AE	Baseline - 90 days after last dose of study treatment		Participants	NUMBER
PRIMARY	Proportion of Participants With Serious Adverse Events (SAEs)	Baseline - 90 days after last dose of study treatment		Proportion expressed as percentage	NUMBER
PRIMARY	Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity	Baseline - 90 days after last dose of study treatment		Proportion expressed as percentage	NUMBER

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Deaths Due to Adverse Events (AEs)	Arm A: Glofit-GemOx		1		Participants
Number of Deaths Due to Adverse Events (AEs)	Arm B: Mosun-GemOx		0		Participants
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Arm A: Glofit-GemOx	AEs leading to treatment discontinuation	5.9		percentage of participants
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Arm B: Mosun-GemOx	AEs leading to treatment discontinuation	16.7		percentage of participants
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Arm A: Glofit-GemOx	AEs leading to dose modification or interruption	29.4		percentage of participants
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs	Arm B: Mosun-GemOx	AEs leading to dose modification or interruption	50.0		percentage of participants
Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria	Arm A: Glofit-GemOx		23.5	95% Confidence Interval 6.81 to 49.90	percentage
Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria	Arm B: Mosun-GemOx		50.0	95% Confidence Interval 11.81 to 88.19	percentage
Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria	Arm A: Glofit-GemOx		35.3		Proportion expressed as percentage
Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria	Arm B: Mosun-GemOx		50.0		Proportion expressed as percentage

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Glofit-GemOx	17
Overall Study	STARTED	Arm B: Mosun-GemOx	6
Overall Study	COMPLETED	Arm A: Glofit-GemOx	5
Overall Study	COMPLETED	Arm B: Mosun-GemOx	3
Overall Study	NOT COMPLETED	Arm A: Glofit-GemOx	12
Overall Study	NOT COMPLETED	Arm B: Mosun-GemOx	3

Source ClinicalTrials.gov

Adverse events250

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Arm A: Glofit-GemOx	6	17	15
other	Anaemia	Blood and lymphatic system disorders	Arm B: Mosun-GemOx	3	6	5
other	Neutropenia	Blood and lymphatic system disorders	Arm A: Glofit-GemOx	4	17	5
other	Neutropenia	Blood and lymphatic system disorders	Arm B: Mosun-GemOx	1	6	8
other	Thrombocytopenia	Blood and lymphatic system disorders	Arm A: Glofit-GemOx	4	17	6
other	Thrombocytopenia	Blood and lymphatic system disorders	Arm B: Mosun-GemOx	2	6	4
other	Tachycardia	Cardiac disorders	Arm A: Glofit-GemOx	0	17	0
other	Tachycardia	Cardiac disorders	Arm B: Mosun-GemOx	1	6	1
other	Blepharitis	Eye disorders	Arm A: Glofit-GemOx	0	17	0
other	Blepharitis	Eye disorders	Arm B: Mosun-GemOx	1	6	1

1 to 10 of 250Source ClinicalTrials.gov

See all 250 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Glofit-GemOx	1	17
Total, all-cause mortality	Arm B: Mosun-GemOx	0	6
Total, other adverse events	Arm A: Glofit-GemOx	17	17
Total, other adverse events	Arm B: Mosun-GemOx	6	6
Total, serious adverse events	Arm A: Glofit-GemOx	12	17
Total, serious adverse events	Arm B: Mosun-GemOx	4	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: Glofit-GemOx vs Arm B: Mosun-GemOx: Number of Deaths Due to Adverse Events (AEs)	Trial comparisons
Arm A: Glofit-GemOx vs Arm B: Mosun-GemOx: Number of Treatment Discontinuations Due to AE	Trial comparisons
Arm A: Glofit-GemOx vs Arm B: Mosun-GemOx: deaths from any cause	Trial comparisons
Arm A: Glofit-GemOx vs Arm B: Mosun-GemOx: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04313608

GET https://conductscience.org/api/trials/v1/NCT04313608/results?page=2

API reference For AI assistants