Trial · NCT06423911
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 24-Week MMR Rate (Part A) | 24 weeks | To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib |
| Primary | 24-Week MMR Rate (Part B) | 24 weeks | To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation |
| Secondary | 96-Week MMR Rate (Part A) | 96 weeks | To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib |
| Secondary | 96-Week MMR Rate (Part B) | 96 weeks | To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation |
| Secondary | Cytogenic Response Rate (Part A) | Through 96 weeks (i.e., at 24, 48, and 96 weeks) | To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib. |
| Secondary | Cytogenic Response Rate (Part B) | Through 96 weeks (i.e., at 24, 48, and 96 weeks) | To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation |
| Secondary | Progression Free Survival (PFS) (Part A) | 5 years after the last patient received the first study dose | To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib |
| Secondary | Progression Free Survival (PFS) (Part B) | 5 years after the last patient received the first study dose | To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation |
| Secondary | Overall Survival (OS) (Part A) | 5 years after the last patient received the first study dose | To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib |
| Secondary | Overall Survival (OS) (Part B) | 5 years after the last patient received the first study dose | To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation |
| Secondary | Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B) | 96 weeks after the last patient received the first study dose | According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed. |
| Secondary | Characterization of population pharmacokinetics of olverembatinib (Parts A and B) | At the end of Cycle 1 and Cycle 2 (each cycle is 28 days) | Blood samples will be collected to measure the plasma concentration of olverembatinib |
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.
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GET https://conductscience.org/api/trials/v1/NCT06423911/registered