Trial · NCT03645395
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Up to 1 year | 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. A DLT is any TEAE that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s). |
| Primary | Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters | Up to 1 year | Laboratory parameters included hematology, blood chemistry, and urinalysis. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented. |
| Primary | Part 1 and 2: Number of Participants With Clinically Significant Physical Findings | Up to 1 year | This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant. |
| Secondary | Part 1 and 2: Plasma Concentrations of MT-3724 | Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 year | Blood samples were collected for Pharmacokinetic (PK) analysis of MT-3724. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination. |
| Secondary | Part 1 and 2: Change From Baseline in B-cell Count | Up to 1 year | Blood samples were collected for analysis of B-cell count. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination. |
| Secondary | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer When Treated With MT-3724 | Up to 1 year | Blood samples were collected for analysis of ADA titer. Data was not collected due to early termination of the trial. |
| Secondary | Part 1 and 2: Number of Participants With Neutralizing Antibody (NAb) Titers When Treated With MT-3724 | Up to 1 year | Blood samples were planed to be collected for analysis of neutralizing antibody (NAb) titers. Data was not collected due to early termination of the trial. |
| Secondary | Part 1 and 2: Number of Participants With Objective Response Rate (ORR) | Up to 1 year | ORR was defined as CR or Partial Response (PR). CR: a score 1 (no uptake above background), 2 (uptake \<=mediastinum), or 3 (\<mediastinum but \<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PR: a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Higher score indicates worse outcomes. |
| Secondary | Part 1 and 2: Duration of Response (DOR) | Up to 1 year | DOR is defined as the time from the first documented complete or partial response to the actual date of disease progression or death before progression. Data was not collected due to early termination of the trial. |
| Secondary | Part 1 and 2: Progression Free Survival (PFS) | Up to 1 year | PFS is defined as the time from first dose date until the first occurrence of documented disease progression or death from any cause in the absence of progressive disease. Data was not collected due to early termination of the trial. |
| Secondary | Part 1 and 2: Overall Survival (OS) | Up to 1 year | OS is defined as the time from date of start of treatment to date of death due to any cause. Data was not collected due to early termination of the trial. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
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GET https://conductscience.org/api/trials/v1/NCT03645395/registered