Trial · NCT05564650
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximally Tolerated Dose (MTD) of Navitoclax in Combination with Venetoclax and Decitabine (Phase I) | Within 30 days of the first dose of study treatment | The Bayesian optimal interval (BOIN) design will be employed to find the MTD. The BOIN design is implemented in a simple way. It is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model based designs. |
| Primary | Complete Response (CR) Rate (Phase II) | Up to cycle 4, an average of 4 months | A 90% confidence interval will be computed for the CR rate by cycle 4. |
| Secondary | Number of Dose-Limiting Toxicities (Phase I) | Within 30 days of the first dose of study treatment | Number of dose-limiting toxicities (Phase I) |
| Secondary | Marrow Complete Response Rate (mCR) (Phase II) | Up to 2 years from enrollment of the last patient | Defined as per International Working Group (IWG) criteria. |
| Secondary | Hematologic Improvement (HI) rate (Phase II) | Up to 2 years from enrollment of the last patient | Defined as per IWG criteria. |
| Secondary | Leukemia Free Survival (LFS) (Phase II) | Up to 2 years from enrollment of the last patient | LFS defined as the time from the date of randomization to the date of diagnosis of AML or death from any cause, whichever came first. |
| Secondary | Overall survival (OS) (Phase II) | Up to 2 years from enrollment of the last patient | Will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported. |
| Secondary | Change in quality of life (QOL) (Phase II) | At baseline | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\]. |
| Secondary | Change in quality of life (QOL) (Phase II) | At 4 months | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\] |
| Secondary | Change in quality of life (QOL) (Phase II) | Up to 2 years from enrollment of the last patient | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\] |
| Secondary | Change in quality of life (QOL) measured by PROMIS-Fatigue (20) (Phase II) | At baseline | Change in quality of life (QOL) as assessed by PROMIS-Fatigue (20). |
| Secondary | Change in quality of life (QOL) measured by PROMIS-Fatigue (20) (Phase II) | At 4 months | Change in quality of life (QOL) as assessed by PROMIS-Fatigue (20) |
| Secondary | Change in quality of life (QOL) measured by PROMIS-Fatigue (20) (Phase II) | Up to 2 years from enrollment of the last patient | Change in quality of life (QOL) as assessed by PROMIS-Fatigue (20) |
| Other | Expression levels of anti-apoptotic BCL-2 family members (Phase II) | At baseline | Assessed by intracellular flow cytometry to determine predictive value for response. Data will be analyzed with FlowJo software. |
| Other | Expression levels of anti-apoptotic BCL-2 family members (Phase II) | after triplet therapy, up to 2 years from enrollment of the last patient | Assessed by intracellular flow cytometry to determine predictive value for response. Data will be analyzed with FlowJo software. |
| Other | Single cell gene expression (Phase II) | At baseline | Ribonucleic acid (RNA) will be isolated from pre-treatment and post-treatment CD19+ cells and used for gene expression profiles (microarray or RNA-Seq). |
| Other | Single cell gene expression (Phase II) | after triplet therapy, up to 2 years from enrollment of the last patient | Ribonucleic acid (RNA) will be isolated from pre-treatment and post-treatment CD19+ cells and used for gene expression profiles (microarray or RNA-Seq). |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT05564650/registered