Trial · NCT07152041
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Day 48 end-of-induction measurable residual diseases (MRD48) after induction remission with olverembatinib and blinatumomab, compared to MRD46 of those treated with dasatinib plus chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts . | Up to approximately 4.5 years. | Primary analysis will be performed by one-sided (Monte-Carlo-) exact chi-square test because the objective calls for testing if the proportion of patients in the \<0.01% Day 48 MRD group is higher than the historical control. The historical control of Day 46 MRD of dasatinib combination with intensive chemotherapy is 80%. It is estimated that VPO+Blinatumomab can increase the negative rate of Day 48 MRD by 10%. a total sample size of 135 provides sufficient power for the planned analyses outlined above if the true D48 MRD negativity probability is 0.90 or higher based on a one-sided alpha of 0.05. |
| Secondary | Day 19 measurable residual diseases (MRD19) during induction remission with olverembatinib plus VP (VOP), compared to MRD19 of those treated with dasatinib plus 4-drug chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts | Approximately 4.5 years. | For this objective a one-sided comparison of probabilities and historical control rate of 40% will be made. Let p2 be the probability of achieving negative D19 MRD on the current study, then the one-sided alternative hypothesis H0: p2=40% vs. H1: p2\>40% will be tested. This analysis will be performed by one-sample one-sided exact binomial test, based on a one-sided alpha of 0.025. The historical control is based on the MRD of patients treated on CCCG-ALL-2015. |
| Secondary | Event-free survival (EFS) of patients treated with this therapy, in comparison to historical regimens. | Approximately 7 years. | The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2, 3 years since diagnosis). Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of EFS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CAMS-Ph+B-ALLRegimen 2025 vs. CCCG-Ph-ALL 2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models. |
| Secondary | Overall survival (OS) of patients treated with this therapy, in comparison to historical regimens | Approximately 7 years. | The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2, 3 years since diagnosis). Comparison of OS functions will be conducted using the two-sided log-rank test. Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of OS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CAMS-Ph+B-ALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models. |
| Secondary | Cumulative incidence of relapse (CIR) of this therapy, in comparison to historical regimens. | Approximately 7 years. | CIR functions of relapse will be estimated by the Kalbafleisch-Prentice method. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of CIR will be performed by Gray's test. Multivariable regression modeling including trial (CAMS-Ph+B-ALLALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Fine-Gray models. |
| Other | To correlate measurable residual diseases (MRD) during remission induction and after consolidation by Ig-NGS, qPCR of BCR::ABL1 and FCM-MRD with cumulative incidence of event-free survival (EFS) | Approximately 7 years | Proportions of patients with positive MRD by NGS, qPCR and FCM on Days 19 and 48 will be estimated by the sample proportion along with the 95% confidence interval. The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2 3 years since diagnosis). Comparisons of OS and EFS will be done by log-trank test, and comparison of CIR will be done by Gray's test. Multivariable regression modeling including trial (CAMS-Ph+B-ALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models. |
| Other | To correlate measurable residual diseases (MRD) during remission induction and after consolidation by Ig-NGS, qPCR of BCR::ABL1 and FCM-MRD with cumulative incidence of relapse(CIR) | Approximately 7 years | Proportions of patients with positive MRD by NGS, qPCR and FCM on Days 19 and 48 will be estimated by the sample proportion along with the 95% confidence interval. The CIR curve will be estimated by Kalbafleisch-Prentice method, along with 95% confidence intervals at specified timepoints (e.g., 2 3 years since diagnosis). Comparisons of CIR will be done by Gray's test. Multivariable regression modeling including trial (CAMS-Ph+B-ALL-2025 vs. CCCGALL2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Fine-Gray models(CIR). |
| Other | To correlate measurable residual diseases (MRD) during remission induction and after consolidation by Ig-NGS, qPCR of BCR::ABL1 and FCM-MRD with overall survival (OS) | Approximately 7 years | Proportions of patients with positive MRD by NGS, qPCR and FCM on Days 19 and 48 will be estimated by the sample proportion along with the 95% confidence interval. The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 2 3 years since diagnosis). Comparisons of OS will be done by log-rank test. Multivariable regression modeling including trial (CAMS-Ph+B-ALL-2025 vs. CCCGALL-2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models. |
| Other | Incidence of Grade 3 or higher Treatment-Emergent Adverse Events (TEAE) associated with olverembatinib, venetoclax and blinatumomab, and compared with the historical controls treated with dasatinib plus intensive chemotherapy. | Up to 30 days after last dose of study treatment | Proportions of grade-3 or higher TEAEs in each treatment phase will be estimated by the sample proportions along with exact 95% confidence intervals. Cumulative incidences of various grade-3 or higher AEs throughout therapy will be estimated by the Kalbafleisch-Prentice method; death, relapse and other events rendering off therapy before completion are regarded as competing risks. |
| Other | To explore the relationship between cellular immunity dynamics during olverembatinib treatment and the efficacy of blinatumomab-contained therapy. | Approximately 7 years | Descriptive statistics including correlation coefficients (Pearson's or Spearman's) and regression modeling including possibly longitudinal data models will be applied as appropriate to analyze the biological associations. Associations between cellular immunity dynamics and relapse will be analysed using Gray's test or Fine-Gray regression models, as appropriate. |
| Other | To explore the pharmacokinetic profiles as Maximum Plasma Concentration [Cmax] in blood paired with cerebrospinal fluid of olverembatinib given alone and in combination with blinatumomab or with prednisone plus vincristine | Up to 30 days after last dose of study treatment | In pharmacokinetic (PK) studies of Cmax, descriptive statistics (mean, standard deviation, median, range) will be used to summarize the data. Visualizations, such as box plots and line graphs, will be used to depict the drug's concentration over time in blood and cerebrospinal fluid. Centers with the appropriate resources may conduct these analyses. |
| Other | To explore the pharmacokinetic profiles as Time to Reach Maximum Plasma Concentration (Tmax) in blood paired with cerebrospinal fluid of olverembatinib given alone and in combination with blinatumomab or with prednisone plus vincristine | Up to 30 days after last dose of study treatment | In pharmacokinetic (PK) studies as Tmax, descriptive statistics (e.g., mean, standard deviation, five-number summary) are used to summarize the data, while visualizations like box plots and line graphs are employed to depict the drug's behavior in the body. It is recommended that centers with the appropriate resources and interest consider undertaking these studies. |
| Other | To explore the pharmacokinetic profiles as Area Under the Plasma Concentration-Time Curve (AUC) in blood paired with cerebrospinal fluid of olverembatinib given alone and in combination with blinatumomab or with prednisone plus vincristine | Up to 30 days after last dose of study treatment | In pharmacokinetic (PK) studies of AUC, descriptive statistics (e.g., mean, standard deviation, five-number summary) are used to summarize the data, while visualizations like box plots and line graphs are employed to depict the drug's behavior in the body. It is recommended that centers with the appropriate resources and interest consider undertaking these studies. |
| Other | To explore the pharmacokinetic profiles as Half-Life (t½) in blood paired with cerebrospinal fluid of olverembatinib given alone and in combination with blinatumomab or with prednisone plus vincristine | Up to 30 days after last dose of study treatment | In pharmacokinetic (PK) studies of t½, descriptive statistics (e.g., mean, standard deviation, five-number summary) are used to summarize the data, while visualizations like box plots and line graphs are employed to depict the drug's behavior in the body. It is recommended that centers with the appropriate resources and interest consider undertaking these studies. |
| Other | To explore the pharmacokinetic profiles as Clearance (CL) in blood paired with cerebrospinal fluid of olverembatinib given alone and in combination with blinatumomab or with prednisone plus vincristine | Up to 30 days after last dose of study treatment | In pharmacokinetic (PK) studies of CL, descriptive statistics (e.g., mean, standard deviation, five-number summary) are used to summarize the data, while visualizations like box plots and line graphs are employed to depict the drug's behavior in the body. It is recommended that centers with the appropriate resources and interest consider undertaking these studies. |
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.
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