Trial · NCT03646123
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Febrile Neutropenia (FN) Rate (Part A) | 7.5 months | The FN rate is defined as the number of participants who experience treatment-emergent FN. |
| Primary | Complete Response (CR) Rate at EOT (Parts B and C) | 7.8 months | CR rate at EOT is defined as the percentage of participants with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson 2016), in participants with previously untreated cHL. |
| Secondary | Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A) | Approximately up to 7.5 months | An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with the treatment. Participants with peripheral neuropathy (PN) adverse events were summarized under AECI. |
| Secondary | Primary Refractory Disease Rate (Part A) | 10.2 months | The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas |
| Secondary | Complete Response Rate (Part A) | 7.2 months | The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014). |
| Secondary | Physician-reported Progression Free Survival (PFS) (Part A) | 24 months | The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology. The determination of antitumor activity will be based on response assessments made according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014). |
| Secondary | Number of Participants With Subsequent Anticancer Therapy Utilization (Part A) | 33.8 months | Number of participants with subsequent anticancer therapy have been reported in this outcome measure. |
| Secondary | Actual Dose Intensity: Brentuximab Vedotin (Part A) | 6.5 months | |
| Secondary | Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A) | 6.5 months | |
| Secondary | Relative Dose Intensity (Part A) | 6.5 months | |
| Secondary | Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A) | 6.5 months | |
| Secondary | Rate of Dose Reduction and Delays: Doxorubicin (Part A) | 6.5 months | |
| Secondary | Rate of Dose Reduction and Delays: Vinblastine (Part A) | 6.5 months | |
| Secondary | Rate of Dose Reduction and Delays: Dacarbazine (Part A) | 6.5 months | |
| Secondary | Incidence of Adverse Events (Parts B and C) | 8.9 months | |
| Secondary | Incidence of Laboratory Abnormalities (Parts B and C) | 8.9 months | Laboratory values were graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). As per NCI CTCAE version 4.03 grading, Grade 1 indicated mild or asymptomatic laboratory abnormalities, Grade 2 indicated moderate laboratory abnormalities, and Grade 3 indicated severe and 4 indicated life-threatening laboratory abnormalities. |
| Secondary | Overall Response Rate (ORR) at EOT (Parts B and C) | Up to 7.8 months | ORR is defined as the percentage of participants with CR or partial response (PR) at EOT according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) in participants with previously untreated cHL. |
| Secondary | Duration of Response (DOR) at End of Study (Parts B and C) | Up to 51.1 months | DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. Duration of response was only calculated for the subgroup of participants achieving a CR or PR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used. |
| Secondary | Duration of Complete Response (DOCR) (Parts B and C) | Up to 51.1 months | DOCR was defined as the time from start of the first documentation of CR to the first documentation of tumor progression (per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. DOCR was calculated for the subgroup of participants achieving CR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used. |
| Secondary | Event Free Survival (EFS) Rate (Parts B and C) | Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | EFS was defined as the time from the start of study treatment to the first documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or progressive disease, whichever occurred first. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. EFS rate was percentage of participants with EFS. |
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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