Trial · NCT07191249
Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .
NCT07191249, Phase 2, Recruiting, Tel-Aviv Sourasky Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma . Trials, record NCT07191249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07191249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .
- NCT number
- NCT07191249
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Conditions
- Follicular Lymphoma
- Interventions
- Mosunetuzumab is a bispecific monoclonal antibody targeting CD20 on B cells and CD3 on T cells, redirecting T cells to eliminate malignant B cells.
- First posted
- 2025-09-24
- Last updated
- 2026-08-11
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria | 6 months | ORR is defined as the proportion of patients who achieved Complete Response or Partial Response determined by Lugano 2014 criteria as assessed by investigators at 6 months after initiation of treatment and prior to the initiation of any subsequent anti-lymphoma therapy. Patients without post-baseline disease assessments will be considered non-responders. |
| Secondary | Progression Free Survival -PFS | up to 24 months after last treatment dose | PFS is defined as the time in months from the first dose of study drug to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving patients without disease progression will be censored at the time of the last adequate disease assessment. Surviving subjects without post-baseline disease assessment will be censored at the date of first dose of study drug. |
| Secondary | Duration of response -DOR | up to 24 months after last treatment dose | DOR is defined for patients who achieved Complete Response (CR) or Partial Response (PR) ('responders'), as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment |
| Secondary | Complete Response Rate - CRR - Lymphoma (FACT-Lym) subscale. | up to 24 months after last treatment dose | CRR is defined as the proportion of patients who achieved Complete Response, determined by Lugano 2014 criteria as assessed by the investigator. All responses of Complete Response after initiation of subsequent anti-lymphoma therapy will be excluded. Subjects without post-baseline disease assessments will be considered as not achieving Complete Response. |
| Secondary | Duration of Complete Response -DOCR | up to 24 months after last treatment dose | DOCR is defined for patients who achieved Complete Response, as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment. |
| Secondary | Time to Next Treatment -TTNT | up to 24 months after last treatment dose | TTNT is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified anti-lymphoma therapy or death due to disease progression. Surviving patients who were reported as not having started new non-protocol-specified anti-lymphoma therapy will be censored at the last known alive date to be free of non-protocol-specified anti-lymphoma therapy. Surviving patients without any post-baseline visit will be censored at the date of the first dose of study drug |
| Secondary | Overall Survival -OS | up to 24 months after last treatment dose | OS is defined as the time in months from the first dose of study drug to death from any cause. Patients who are still alive at the end of the study or at the time of the analyses (12 and 24 months after the first dose of study drug) will be censored at the last known alive date |
| Secondary | Statistical Analysis for Safety | from first dose through 90 days after administration of last dose | Incidence of adverse events (AEs) and abnormal laboratory test results - including all AEs, treatment-emergent AEs (TEAEs), Adverse drug reactions (ADRs), SAEs, AEs leading to discontinuation, and AEs leading to death. |
| Secondary | Health related quality of life | whole treatment period- 6 months | Health-related quality of life will be assessed using the FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) questionnaire. |
| Other | Exploratory Biomarker Research Endpoints: Longitudinal measurement of ctDNA in the peripheral blood (PB), before and during treatment, at disease progression, at CR and one year after achievement of CR, as a biomarker for long-term remission | up to one year after achievement CR | Longitudinal measurement of ctDNA in the peripheral blood (PB), before and during treatment, at disease progression, at CR and one year after achievement of CR, as a biomarker for long-term remission; |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
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/NCT07191249
GET https://conductscience.org/api/trials/v1/NCT07191249/registered