Trial · NCT05171647
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) | Up to approximately 23.8 months | ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off. |
| Primary | Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria. |
| Secondary | ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population | Up to 32 months | ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off. |
| Secondary | ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population | Up to approximately 58 months | ORR was defined as the percentage of participants with CR or PR, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Duration of Response (DoR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | DoR was defined as the time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria. |
| Secondary | DoR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | DoR=time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per investigator, per Lugano Response Criteria. |
| Secondary | Overall Survival (OS) | Up to 32 months | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. |
| Secondary | PFS as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | PFS was defined as the time from randomization to first occurrence of PD or death from any cause, whichever occurred first, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Complete Response Rate (CRR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the IRF, per Lugano Response Criteria. |
| Secondary | CRR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Duration of Complete Response (DOCR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | DOCR was defined as the time from first occurrence of a documented CR to PD, per IRF, per Lugano Response Criteria. |
| Secondary | DOCR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | DOCR=time from first occurrence of documented CR to PD, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Time to Deterioration in Physical Functioning (PF), as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30 (EORTC QLQ-C30) | Up to approximately 58 months | Time to deterioration in PF was defined as time from randomization to the first documentation of 10-point or more decrease, from baseline. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), global health status (GHS)/quality of life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning scales were scored on a 4-point scale, ranging from 1=Not at all to 4=Very much. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for a functioning scale indicated high/healthy level of functioning. |
| Secondary | Time to Deterioration in Fatigue Scale, as Measured by the EORTC QLQ-C30 | Up to approximately 58 months | Time to deterioration in fatigue was defined as time from randomization to the first documentation of 10-point or more decrease, from baseline. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), global health status (GHS)/quality of life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Fatigue scale was scored on a 4-point scale, ranging from 1=Not at all to 4=Very much. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for a fatigue scale indicated a high level of symptom severity. |
| Secondary | Time to Deterioration in Lymphoma Symptoms, as Measured by Functional Assessment of Cancer Therapy- Lymphoma Questionnaire (FACT- Lym LymS) | Up to approximately 58 months | Time to deterioration in lymphoma-specific symptoms was defined as the time from randomization to the first documentation of a 3-point or more decrease, from baseline. FACT-Lym is a cancer-specific scale used to assess health-related QoL aspects relevant to participants with lymphoma. The full measure consists of the FACT-G physical, social/family, emotional, and functional well-being scales (27 items), as well as lymphoma-specific symptoms subscale (LymS). The FACT-Lym Lyms consists of 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score ranges from 0 to 60, where a high score indicated a better QoL. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately 58 months | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. |
| Secondary | Number of Participants With Cytokine Release Syndrome (CRS) With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale | Up to approximately 58 months | CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS. |
| Secondary | Number of Participants With Dose Interruptions, Dose Reductions and Study Treatment Discontinuation Due to AEs | Up to approximately 58 months | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. Participants who had dose interruptions or modifications or who discontinued study treatment due to AEs will be reported here. |
| Secondary | Dose Intensity of Mosunetuzumab | Up to approximately 58 months | |
| Secondary | Change From Baseline in Peripheral Neuropathy (PN), as Measured by the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) | Up to approximately 58 months | The FACT/GOG-Ntx is an 11-item patient-reported outcome that measures polatuzumab vedotin-induced PN. The scale contains 4 subscales to assess sensory neuropathy (4 items), hearing neuropathy (2 items), motor neuropathy (3 items), and dysfunction associated with neuropathy (2 items), which can be summed to create a total score. Each item is scored on a 5-point response scale that ranges from 0=not at all to 4=very much. The possible range for the scores is 0-44, with higher scores indicating more extreme neuropathy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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