Trial · NCT02361346
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 51
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Days 1, 3, 5, 8, 10 and 12 | The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Primary | Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1 and 2 : Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274. |
| Primary | Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of tmax. |
| Primary | Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast. |
| Primary | Part 1 and 2: Half Life (t1/2) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724. |
| Primary | Part 1 and 2: Volume of Distribution (Vz) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724. |
| Primary | Part 1 and 2: Clearance (CL) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724. |
| Primary | Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes | Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study) | CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus |
| Primary | Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed | Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study) | Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented. |
| Primary | Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. |
| Primary | Part 3: Number of Participants With Clinically Significant Laboratory Parameters | Up to Day 45 | Blood samples were collected at indicated timepoints for the analysis of laboratory parameters. |
| Primary | Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values | Up to Day 26 | Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position. |
| Primary | Part 3: Number Participants With Clinically Significant Vital Signs | Up to Day 45 | Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points. |
| Primary | Part 3: Number of Participants With Clinically Significant Physical Findings | Up to Day 26 | Physical examination was performed by a physician or a qualified delegate at the investigating site. |
| Primary | Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review. |
| Secondary | Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. |
| Secondary | Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma | Up to Day 45 | Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board. |
| Secondary | Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment. |
| Secondary | Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression. |
| Secondary | Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL | Up to Day 45 | DCR defined as percentage of participants who have achieved CR, PR and stable disease. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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