Trial · NCT03900949
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 | Maximum-tolerated dose (MTD) of combining gemtuzumab ozogamicin with cytarabine, daunorubicin, and midostaurin | 42 days after start of last induction (i.e. induction or re-induction) | The MTD will be estimated using isotonic regression. An incidence of dose limiting toxicity at each dose level will be summarized. |
| Secondary | Incidence of 30-day treatment-related mortality | Up to 30 days after receiving initial induction therapy | Will be estimated with exact confidence intervals. |
| Secondary | Rate of complete composite remission (CCR) | At end of consolidation treatment (up to 120 days) | Complete composite remission is defined as meeting criteria for complete remission (CR), complete remission with incomplete blood count recovery (CRi), or complete remission with incomplete platelet recovery (CRp). Will be measured and reported with 95% exact confidence intervals. |
| Secondary | Objective response rate (ORR) | At end of consolidation treatment (up to 120 days) | ORR is defined as the sum of CR, CRi, Morphologic leukemia-free state (MLFS), and Partial remission (PR). Will be measured and reported with 95% exact confidence intervals. |
| Secondary | Event free survival | From date of primary refractory disease, or relapse from complete response (CR) or complete remission with incomplete blood count recovery (CRi) , or death from any cause, assessed up to 24 months | EFS will be measured from start of on-study therapy (i.e., Day 1) to the date of primary refractory disease, relapse from CR or CRi, or death from any cause. Participants not known to have failed induction therapy, relapsed, or died at time of last follow-up will be censored on the date they were last examined (i.e., 2 years following completion of on-study therapy). The Kaplan-Meier method will be used. Mean and/or median survival and 95% confidence intervals will be reported, if available. |
| Secondary | Duration of response | From date of first documented response (CR, CRi) to date of documented relapse, assessed up to 24 months | For only participants that achieve CR or CRi, the DoR is measured from the date of first documented response (CR, CRi) until the date of relapse. Participants not known to have relapsed at time of last follow-up will be censored on the date they were last examined (i.e., 2 years following completion of on-study therapy). The Kaplan-Meier method will be used. Mean and/or median survival and 95% confidence intervals will be reported, if available. |
| Secondary | Relapse-free survival | From date of first documented response (CR, CRi) to date of relapse or death from any cause, assessed up to 24 months | For only participants that achieve CR or CRi, RFS will be measured from the date of first documented response (CR, CRi) to the date of relapse or death from any cause. Participants not known to have relapsed or died at time of last follow-up will be censored on the date they were last examined (i.e., 2 years following completion of on-study therapy). The Kaplan-Meier method will be used. Mean and/or median survival and 95% confidence intervals will be reported, if available. |
| Secondary | Overall survival | From start of treatment until death, assessed up to 24 months | The Kaplan-Meier method will be used. Mean and/or median survival and 95% confidence intervals will be reported, if available. |
| Secondary | Incidence of adverse events and serious adverse events | Up to 90 days after last dose of treatment | Will be tabulated and summarized by severity and major organ site according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Other | CD33 expression | Up to 24 months | Will be summarized descriptively. CD33 expression will be correlated with CCR and ORR using Fisher's exact test and with time-to-event endpoints using a log-rank test. |
| Other | CD33 single nucleotide polymorphism (SNP) | Up to 24 months | Will be summarized descriptively. The presence/absence of CD33 SNPs will be correlated with CCR and ORR using Fisher's exact test and with time-to-event endpoints using a log-rank test. |
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/NCT03900949/registered