Trial · NCT04264806
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 4 years | ORR is a composite of complete remission (CR), partial remission (PR) and marrow complete remission (mCR) as per modified International Working Group (IWG) criteria. |
| Secondary | Percentage of Participants Achieving Complete Remission (CR) | Up to 4 years | Percentage of participants achieving CR as per IWG criteria will be reported. |
| Secondary | Percentage of Participants who Achieve Transfusion Independence | Up to 4 years | Percentage of participants who achieve transfusion independence will be reported. Transfusion independence is defined as a period of greater than or equal to (\>=) 56 consecutive days with no transfusion occurring between the first and last dose of study drug +30 days. |
| Secondary | Time to Transformation of Participants to Acute Myeloid Leukemia (AML) | Up to 4 years | Time to transformation of participants to AML will be reported. Transformation to AML is defined as \>= 20% bone marrow blasts. |
| Secondary | Progression Free Survival (PFS) | Up to 4 years | PFS is defined as the time from randomization to disease progression; relapse from CR, PR, or mCR; or death from any cause. |
| Secondary | Overall Survival (OS) | Up to 4 years | OS is defined as the time from randomization to death. |
| Secondary | Hematologic Improvement Rate | Up to 4 years | Hematologic improvement rate is defined as erythroid response (pretreatment, less than (\<) 11 g/dL; hemoglobin \>= 1.5 g/dL; relevant reduction of units of RBC transfusions by an absolute number of \>= 4 Red blood cell (RBC) transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of \<= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation; platelet response (pretreatment \<100\*10\^9/L); absolute increase of \>= 30\*109/L for participants starting with \>20\*10\^9/L platelets; increase to \>20\*109/L and by \>= 100% for participants starting with \<= 20\*109/L platelets; Neutrophil response (pretreatment \<1.0×10\^9/L); and at least 100% increase and an absolute increase of \>0.5\*10\^9/L. |
| Secondary | Percentage of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 4 years | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Percentage of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to 4 years | Percentage of participants with clinically significant abnormalities in laboratory parameters will be reported. |
| Secondary | Area Under the Serum Concentration-Time Curve Within Timespan t1 to t2 (AUC[t1-t2]) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | The AUC(t1-t2) is the area under the serum concentration-time curve within timespan t1 to t2. |
| Secondary | Maximum Serum Concentration (Cmax) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | Cmax is the maximum observed serum concentration. |
| Secondary | Minimum Serum Concentration (Cmin) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | Cmin is the minimum observed serum concentration. |
| Secondary | Elimination Half-Life (t1/2) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). |
| Secondary | Systemic Clearance (CL) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Secondary | Volume of Distribution (Vz) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. |
| Secondary | Number of Participants with Developed Antidrug Antibodies to Cusatuzumab | Cycle 1: Day 3 (Predose); Cycle 1: Day 17 (Predose); Cycle 2: Day 3 (Predose); Cycle 8 and 11: Day 3 (Predose) and EOT (up to 4 years) | Venous blood samples are analyzed for presence of antidrug antibodies to cusatuzumab. Participants with titer of confirmed positive samples for cusatuzumab antibodies are reported. |
| Secondary | Percentage of Participants Achieving Complete Remission (CR) and Partial Remission (PR) | Up to 4 years | Percentage of participants achieving CR and PR as per IWG criteria will be reported. |
| Secondary | Time to response | Up to 4 years | Time to response for participants who achieved CR, PR and mCR responses, defined as time from randomization to achieving the first response of CR, PR, or mCR as per modified IWG criteria. |
| Secondary | Duration of response | Up to 4 years | Time from achieving the first response of CR, PR, or mCR to relapse or death from any cause for those participants who responded. |
| Secondary | Percentage of Participants With Clinically Meaningful Improvement in Functional Assessment of Cancer Therapy - Anemia Trial Outcome Index (FACT-An TOI) Total Score | Up to 4 years | FACT-An is a scale in Functional Assessment of Chronic Illness Therapy Measurement System. It consists of Functional Assessment of Cancer Therapy (general version; FACT-G) and 20 questions labeled "additional concerns" that measure anemia/fatigue. FACT-G is 27-item compilation of general questions divided into 4 primary quality of life domains: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. Participants will be asked to rate scale items as it applies to past 7 days, on 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). Negatively stated items will be reversed by subtracting the response from 4. After reversing the proper items, items are summed to a total to generate a score on (sub)scale. A summary Trial Outcome Index total score (FACT An TOI) will be calculated by summing physical well being, functional well being, and anemia symptoms subscales and higher is the score better is the quality of life. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04264806/registered