Trial · NCT04323956
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of parsaclisib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (Phase I) | Up to 21 days | The MTD will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in in at least one-third of patients (at least 2 of a maximum of 6 patients). |
| Primary | Complete metabolic response (CMR) rate (Dose Expansion) | Up to end of treatment (3-4 weeks after day 1 of cycle 6 [each cycle is 21 days]) | Will be measured by positron emission tomography (PET). A success is defined as an objective status of CMR by the PET-computed tomography (CT) based response criteria at the end of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of complete metabolic response will be calculated. |
| Secondary | Incidence of adverse events (AEs) (Phase I) | Up to 2 years | The number and severity (grade) of all treatment related AEs will be tabulated and summarized. Non-hematologic AEs will be evaluated via the ordinal Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 standard AE grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTCAE v 5.0 standard AE grading. Both all grade and grade 3 and above AEs will be described and summarized in a similar fashion. Overall AE incidences as well as AE profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. |
| Secondary | Incidence of toxicity due to parsaclisib in combination with Pola-R-CHP (Pola Safety Lead-in) | Up to cycle 1 (21 days) | Toxicity will be measured per NCI-CTCAE version 5. Significant toxicity is defined as an adverse event occurring during the first cycle of treatment that is possibly, probably, or definitely related to study treatment. |
| Secondary | Objective response rate (Dose Expansion) | Up to end of treatment (3-4 weeks after day 1 of cycle 6 [each cycle is 21 days]) | Will be estimated by the number of patients with an objective status of CMR or partial metabolic response (PMR) by the PET-CT based response criteria at the end of treatment divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true objective response rate will be calculated. |
| Secondary | Duration of response (Dose Expansion) | Up to 2 years | Defined as the date at which the patient's objective status is first noted to be either CMR or PMR to the earliest date progression is documented by CT or PET/CT \[progressive metabolic disease (PMD) or progressive disease (PD)\] |
| Secondary | Event-free survival (Dose Expansion) | Up to 5 years | Defined as the time from registration to disease progression or relapse (PMD or PD), initiation of subsequent anti-lymphoma therapy, or death due to any cause. |
| Secondary | Progression-free survival (Dose Expansion) | Up to 5 years | Defined as the time from registration to progression (PMD or PD) or death due to any cause |
| Secondary | Overall survival (Pola Safety Lead-in) | Up to 5 years | Defined as the time from registration until death due to any cause. |
| Secondary | Incidence of adverse events (Dose Expansion) | Up to 2 years | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. |
| Secondary | Objective response rate (Pola Safety Lead-in) | Up to end of treatment [3-4 weeks after day 1 of cycle 6 (each cycle is 21 days)] | Will be estimated by the number of patients with an objective status of CMR or PMR by the PET-CT based response criteria at the end of treatment divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true objective response rate will be calculated. |
| Secondary | Duration of response (Pola Safety Lead-in) | Up to 2 years | Defined as the date at which the patient's objective status is first noted to be either CMR or PMR to the earliest date progression is documented by CT or PET/CT (PMD or PD) |
| Secondary | Event-free survival (Pola Safety Lead-in) | Up to 5 years | Defined as the time from registration to disease progression or relapse (PMD or PD), initiation of subsequent anti-lymphoma therapy, or death due to any cause |
| Secondary | Progression-free survival (Pola Safety Lead-in) | Up to 5 years | Defined as the time from registration to progression (PMD or PD) or death due to any cause |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04323956/registered