Trial · NCT03677141
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
NCT03677141, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2024-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma. Trials, record NCT03677141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03677141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
- NCT number
- NCT03677141
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 117 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Interventions
- Mosunetuzumab, Polatuzumab Vedotin, Rituxumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tocilizumab
- First posted
- 2018-09-19
- Last updated
- 2024-12-18
- Other registries' IDs
- eudract:2018-001039-29
- Results first posted
- 2024-12-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) | 6-8 weeks after either C6D1 or last dose of study treatment | The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria. |
| Secondary | CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | |
| Secondary | Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | ORR is defined as a CR or PR at the time of primary assessment based on PET-CT, as determined by the investigator. |
| Secondary | ORR at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | ORR is defined as a CR or PR at the time of primary assessment based on CT only, as determined by the investigator. |
| Secondary | Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II) | Up to approximately 50 months | Best ORR was defined as CR or PR at any time on study and based on PET-CT or CT only as determined by the investigator. |
| Secondary | Duration of Response (DOR) as Determined by the Investigator (Phase II) | Up to approximately 50 months | DOR is defined as the time from the first occurrence of a documented objective response to disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). |
| Secondary | Progression-free Survival (PFS) as Determined by the Investigator (Phase II) | Up to approximately 50 months | PFS is defined as the time from randomization to the first occurrence of disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The earliest contributing event to PFS is reported. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day). |
| Secondary | PFS at 1 Year as Determined by the Investigator (Phase II) | 1 year | PFS at 1 year is defined as the proportion of participants with disease progression or relapse as determined by the investigator, or death from any cause within 1 year of randomization. |
| Secondary | Event-free Survival (EFS) as Determined by the Investigator (Phase II) | Up to 50 months | EFS is defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). |
| Secondary | Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale | C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) | 6-8 weeks after either C6D1 or last dose of study treatment | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. The primary efficacy analysis compared Arm 1 vs Arm 2, with participants grouped according to the treatment arm assigned at randomization. Group C was included in secondary efficacy analysis, and efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | ORR at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II) | Up to approximately 50 months | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of responders | NUMBER |
| SECONDARY | Duration of Response (DOR) as Determined by the Investigator (Phase II) | Up to approximately 50 months | The number of participants analyzed was the number of participants with a PR or CR in each arm. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). Efficacy analyses for Arms A1, A2, and B were exploratory. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Determined by the Investigator (Phase II) | Up to approximately 50 months | Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day). | Months | MEDIAN |
| SECONDARY | PFS at 1 Year as Determined by the Investigator (Phase II) | 1 year | Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) as Determined by the Investigator (Phase II) | Up to 50 months | Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment or documentation of NALT were censored at the date of randomization or first study treatment, plus 1 day). | Months | MEDIAN |
| SECONDARY | Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale | C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation) | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol. | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 72.5 | 95% Confidence Interval 56.11 to 85.40 | Percentage of participants | |
| Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 77.3 | 95% Confidence Interval 54.63 to 92.18 | Percentage of participants | |
| CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | Group C: Phase II Mosunetuzumab + CHOP | 50.0 | 95% Confidence Interval 33.80 to 66.20 | Percentage of participants | |
| CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 47.5 | 95% Confidence Interval 31.51 to 63.87 | Percentage of participants | |
| CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 31.8 | 95% Confidence Interval 13.86 to 54.87 | Percentage of participants | |
| Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | Group C: Phase II Mosunetuzumab + CHOP | 87.5 | 95% Confidence Interval 73.20 to 95.81 | Percentage of participants | |
| Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 80.0 | 95% Confidence Interval 64.35 to 90.95 | Percentage of participants | |
| Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 77.3 | 95% Confidence Interval 54.63 to 92.18 | Percentage of participants | |
| ORR at PRA Based on CT Only as Determined by the Investigator (Phase II) | Group C: Phase II Mosunetuzumab + CHOP | 85.0 | 95% Confidence Interval 70.16 to 94.29 | Percentage of participants | |
| ORR at PRA Based on CT Only as Determined by the Investigator (Phase II) | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 72.5 | 95% Confidence Interval 56.11 to 85.40 | Percentage of participants |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A1: Phase Ib Mosunetuzumab + CHOP | 3 | |
| Overall Study | STARTED | Group A2: Phase Ib Mosunetuzumab + CHOP | 4 | |
| Overall Study | STARTED | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 8 | |
| Overall Study | STARTED | Group C: Phase II Mosunetuzumab + CHOP | 40 | |
| Overall Study | STARTED | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 40 | |
| Overall Study | STARTED | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 22 | |
| Overall Study | COMPLETED | Group A1: Phase Ib Mosunetuzumab + CHOP | 1 | |
| Overall Study | COMPLETED | Group A2: Phase Ib Mosunetuzumab + CHOP | 3 | |
| Overall Study | COMPLETED | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 1 | |
| Overall Study | COMPLETED | Group C: Phase II Mosunetuzumab + CHOP | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,596
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 | Group A1: Phase Ib Mosunetuzumab + CHOP | 2 | 3 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Group A2: Phase Ib Mosunetuzumab + CHOP | 2 | 4 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 2 | 8 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Group C: Phase II Mosunetuzumab + CHOP | 17 | 40 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 9 | 38 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 5 | 22 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group A1: Phase Ib Mosunetuzumab + CHOP | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group A2: Phase Ib Mosunetuzumab + CHOP | 1 | 4 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 1 | 8 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group C: Phase II Mosunetuzumab + CHOP | 2 | 40 | 2 |
1 to 10 of 1,596Source ClinicalTrials.gov
See all 1,596 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A1: Phase Ib Mosunetuzumab + CHOP | 2 | 3 |
| Total, all-cause mortality | Group A2: Phase Ib Mosunetuzumab + CHOP | 1 | 4 |
| Total, all-cause mortality | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 6 | 8 |
| Total, all-cause mortality | Group C: Phase II Mosunetuzumab + CHOP | 9 | 40 |
| Total, all-cause mortality | Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized) | 5 | 40 |
| Total, all-cause mortality | Arm 2: Phase II Rituximab + CHP-Pola (Randomized) | 3 | 22 |
| Total, other adverse events | Group A1: Phase Ib Mosunetuzumab + CHOP | 3 | 3 |
| Total, other adverse events | Group A2: Phase Ib Mosunetuzumab + CHOP | 4 | 4 |
| Total, other adverse events | Group B: Phase Ib Mosunetuzumab + CHP-Pola | 8 | 8 |
| Total, other adverse events | Group C: Phase II Mosunetuzumab + CHOP | 40 | 40 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03677141
GET https://conductscience.org/api/trials/v1/NCT03677141/results?page=2