Trial · NCT07021989
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with a complete response | Up to 4 cycles (a cycle is 21 days) | To determine the ctDNA/MRD negative, PET negative complete response rate for cHL, participants undergoing treatment with pembro + GVD will have a composite response incorporating the following two criteria: (1) Absence of detectable cHL ctDNA as assessed by Foresight CLARITY LDT after 2 cycles of treatment and (2) complete response by Fluorodeoxyglucose (FDG) PET/CT, assessed by Lugano criteria after 2 cycles, or 4 if participant demonstrates indeterminate response (IR) after 2 cycles. Lugano classification for response using FDG PET-CT is as follows: A score is given which ranges from 1 (No uptake above background) to 5 (Hottest area of uptake markedly \> liver and/or new lesions present). A CR is defined as a score of 1,2,3 in nodal or extranodal sites with or without a residual mass. Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) will be used to distinguish IR, SD or PD. Response rate will be summarized by percentage, along with 95% confidence intervals. |
| Secondary | Progression-free survival (PFS) rate for participants without Autologous Stem Cell Transplant (ASCT) | Up to 2 years | PFS rate is defined as the proportion of participants alive without disease from initiation of study therapy to progression or death by any cause, whichever occurs first for up to 2 years after participants receive study therapy and non-transplant consolidation. The censoring time for PFS will be the date of the last study assessment for progression. PFS will be analyzed descriptively using Kaplan-Meier methods. |
| Secondary | Overall Survival (OS) rate for participants without ASCT | Up to 2 years | OS rate is defined as the proportion of participants alive from initiation of study therapy to death by any cause for up to 2 years after participants receive study therapy and non-transplant consolidation. The censoring time for OS will be the date of the last study contact. OS will be analyzed descriptively using Kaplan-Meier methods. |
| Secondary | Overall PFS rate | Up to 2 years | Overall PFS rate is defined as proportion of participants alive without disease from initiation of study therapy to progression or death by any cause, whichever occurs first for up to 2 years after participants receive study therapy. The censoring time for PFS will be the date of the last study assessment for progression. PFS will be analyzed descriptively using Kaplan-Meier methods. |
| Secondary | Overall survival rate | Up to 2 years | OS rate is defined as the proportion of participants alive from initiation of study therapy to death by any cause for up to 2 years after participants receive study therapy. The censoring time for OS will be the date of the last study contact. OS will be analyzed descriptively using Kaplan-Meier methods. |
| Secondary | Proportion of participants undergoing ASCT | Up to 2 years | The proportion of participants undergoing ASCT is defined as the number of participants having received an autologous stem cell graft over the total number of participants. |
| Secondary | Percentage of participants with presence cHL ctDNA | Up to | The percentage of participants with the presence of absence of detectable ctDNA through 2 cycles of pembrolizumab (pembro) + GVD will be reported. |
| Secondary | Percentage of participants with presence of detectable metabolically active disease | Up to 2 years | The percentage of participants with the presence of absence of detectable metabolically active disease on an FDG PET/CT at any time during the course of treatment with Pembro+GVD will be reported. |
| Secondary | Number of participants reporting treatment-emergent Adverse Events (AEs) of significant interest | From start of treatment until 90 days after discontinuation of treatment, approximately 2 years | The number of participants reporting Adverse Events (AEs) will be descriptive and performed based on the safety population. Serious Adverse Events (SAEs), Immune-related Adverse Events (irAEs), AEs classified as Grade 3 or higher per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5, and AEs resulting in discontinuation of treatment, withdrawal from the study will be tabulated. |
| Secondary | Change in mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) over time | Up to 5 years | The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning. Mean scores and standard deviations will be reported. |
| Secondary | Change in mean scores on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) survey over time | Up to 5 years | The COST-FACIT is an 11-item measure used to assess financial toxicity. Each item is measured on a five-point Likert scale (0 = not at all, 4 = very much), with recall based on the past 7 days related to the participant's disease management. A score is computed by first reverse coding seven items, then taking the sum of all items, multiplying the sum by the number of items on the scale, and dividing that number by the number of items answered. Higher scores indicate better Financial Well-Being. Mean scores and standard deviations will be reported. |
| Secondary | Percentage of participants with detectable cHL ctDNA at baseline | Up to 30 days | Percentage of all participants with detectable cHL ctDNA in the plasma at baseline will be reported. Participants not meeting this criterion will be excluded from the study, but genotype failures will be recorded for the purpose of this endpoint. |
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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