Trial · NCT06453044
Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma
NCT06453044, Phase 2, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma. Trials, record NCT06453044. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06453044
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma
- NCT number
- NCT06453044
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3a Follicular Lymphoma, Refractory Grade 1 Follicular Lymphoma, Refractory Grade 2 Follicular Lymphoma, Refractory Grade 3a Follicular Lymphoma
- Interventions
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Mosunetuzumab, Polatuzumab Vedotin, Positron Emission Tomography, Questionnaire Administration
- First posted
- 2024-06-11
- Last updated
- 2026-09-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of grade 3 or higher adverse events (AEs) | Up to completion of first 2 cycles of treatment - each cycle is 28 days | Unacceptable toxicity will be defined as events occurring during the first 2 cycles of treatment that is at least possibly related to study treatment. Observed toxicities will be summarized by type, severity, and attribution. |
| Primary | Complete response (CR) rate | Up to 36 months after last dose of protocol therapy | CR rate will be defined as the proportion of response-evaluable participants that achieve a best response of CR after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. CR rate will be estimated along with the 95% exact binomial confidence interval. |
| Secondary | Incidence of AEs | Up to 30 days from last dose of protocol therapy | AEs will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Cytokine release syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Criteria. Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) will be graded according to the ASTCT ICANS Consensus Grading Criteria. Observed toxicities will be summarized by type, severity, and attribution. |
| Secondary | Overall response rate (ORR) | Up to 36 months after last dose of protocol therapy | ORR will be defined as the proportion of response-evaluable participants that achieve a best response of CR or partial response (PR) after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated along with the 95% exact binomial confidence interval. |
| Secondary | Time to first CR | At start of protocol therapy to CR up to 36 months after last dose of protocol therapy | Time to first CR will be defined as the time from start of protocol therapy until the time the patients first achieve CR. Time for first CR will be summarized by descriptive statistics. |
| Secondary | Time to best response | At start of protocol therapy to first best response up to 36 months after last dose of protocol therapy | Time to best response will be defined as the time from start of protocol therapy until the time the patients achieve first best response (CR or PR). Time to best response will be summarized by descriptive statistics. |
| Secondary | Duration of response (DOR) | At first PR or CR to progression or death up to 36 months after last dose of protocol therapy | DOR will be defined as the time from first achievement of PR or CR to time of progression or death, whichever is earlier. DOR will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when available. |
| Secondary | Duration of response among CR (DORC) | At CR up to 36 months after last dose of protocol therapy | DORC will be limited to patients who achieve a best response of CR. DORC will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. |
| Secondary | Progression-free survival (PFS) | At start of protocol treatment to disease relapse/progression or death up to 36 months after last dose of protocol therapy | PFS will be defined as the duration of time from start of protocol treatment to time of disease relapse or progression to death due to any cause, whichever occurs earlier. PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when available. |
| Secondary | Overall survival (OS) | At start of protocol treatment to death up to 36 months after last dose of protocol therapy | OS will be defined as the duration of time from start of protocol treatment to time of death due to any cause.OS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median OS will be estimated when available. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT06453044
GET https://conductscience.org/api/trials/v1/NCT06453044/registered