Trial · NCT07387926
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 | Part 1 Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) occurring during cycle 1 (debulking induction) | During Cycle 1 (Cycle 1 = 28 days) | A dose-limiting toxicity (DLT) is defined as an adverse event which starts between Day 1 and Day 28, is suspected by the investigator to be related to asciminib, and meets one of the several criteria. |
| Primary | Part 1 Dose Escalation: Incidence and severity of adverse events (AEs) during cycle 1 (debulking induction) | During Cycle 1 (Cycle = 28 days) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Primary | Part 2 Dose Expansion: Percentage of complete response/remission (CR) evaluable participants who achieve CR treated at recommended phase 2 dose (RP2D) (debulking induction) | End of Cycle 1 (Cycle 1 = 28 days) | Participants with Complete Response/Remission (CR) will achieve the following: No circulating blasts or extramedullary disease; No lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass/CNS involvement; Marrow \<5% blasts (M1) OR \< 1% blasts by flow cytometry. If a discrepancy occurs between disease detection methods, the result of the flow cytometry assay will be used to determine CR status; Peripheral blood count recovery; ANC \> 1000μL and platelets \> 100,000μL. CR evaluable: Participants will be considered CR evaluable for Part 2 if they have relapsed/refractory Ph+ ALL defined as either \>1% bone marrow (BM) blasts by MFC or immunoglobulin/T-cell receptor (IG/TCR) PCR, OR \> 5% BM blasts by morphologic evaluation at enrollment and are treated at RP2D. |
| Secondary | Complete remission (CR) rate | End of Cycle 2 and Cycle 3 (Cycle 2 & 3 = 42 days) | Percentage of participants who had a CR |
| Secondary | Overall response rate (ORR) | At and by the end of Cycle 1 (Cycle 1 = 28 days), Cycle 2, and Cycle 3 (Cycle 2 & 3 = 42 days) | Percentage of participants who had CR and/or complete remission with incomplete blood count recovery (CRi) |
| Secondary | Next generation sequencing (NGS) minimal residual disease (MRD) negative rate | At and by the end of Cycle 1 (Cycle 1 = 28 days), Cycle 2, and Cycle 3 (Cycle 2 & 3 = 42 days) | Percentage of participants who have NGS MRD negative CR at and by the end of cycle 1 (debulking induction), cycle 2 and cycle 3 (consolidation). |
| Secondary | Multiparametric flow cytometry (MFC) MRD negative CR rate | At and by the end of Cycle 1 (Cycle 1 = 28 days), Cycle 2, and Cycle 3 (Cycle 2 & 3 = 42 days) | Percentage of participants who have MFC MRD negative CR at and by the end of cycle 1 (debulking induction), cycle 2 and cycle 3 (consolidation). |
| Secondary | Overall MRD negative response (MRD negative CR and/or CRi rate) by NGS | at and by the end of cycle 1 (debulking induction) (Cycle 1 = 28 days), cycle 2, and cycle 3 (consolidation) (each cycle = 42 days) | Overall MRD negative response is the percentage of participants who have NGS MRD negative complete response (CR) and complete response incomplete blood count recovery (CRi). |
| Secondary | Overall MRD negative response (MRD negative CR and/or CRi rate) by MFC | at and by the end of cycle 1 (Cycle 1 = 28 days) (debulking induction), cycle 2, cycle 3 (consolidation) (each cycle = 42 days) | Overall MRD negative response is the percentage of participants who have MFC MRD negative complete response (CR) and complete response incomplete blood count recovery (CRi). |
| Secondary | Disease Free Survival (DFS) | End of Cycle 3 (Cycle 3 = 42 days) in Part 2 of the study and at the end of study (EOS = approx. 3 years) | The period from when a participant is in remission until they have relapse or death due to any reason. |
| Secondary | Overall survival (OS) | End of Cycle 3 (Cycle 3 = 42 days) in Part 2 of the study and at the end of study (EOS = approx. 3 years) | The duration of time from treatment initiation until the participant's death due to any reason. |
| Secondary | Pharmacokinetic (PK) parameter of asciminib at steady state: AUClast | Cycle 1, Day 8 (Cycle 1 = 28 days) | Area Under the Curve to the Last Measurable Concentration-represents the total drug exposure (area under the plasma concentration-time curve) from the time of administration until the last measurable concentration |
| Secondary | PK parameter of asciminib at steady state: Cmax | Cycle 1, Day 8 (Cycle 1 = 28 days) | Maximum concentration-the peak (highest) plasma drug concentration observed after administration |
| Secondary | PK parameter of asciminib at steady state: Tmax | Cycle 1, Day 8 (Cycle 1 = 28 days) | The time it takes to reach the Cmax after drug administration |
| Secondary | PK parameter of asciminib at steady state: Ctrough | Cycle 1, Day 8 (Cycle 1 = 28 days); Cycle 2, Day 22 (Cycle 2 = 42 days); Cycle 3, Day 22 (Cycle 3 = 42 days) | Trough concentration- lowest drug concentration observed, typically right before the next dose is administered (steady-state condition) |
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
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GET https://conductscience.org/api/trials/v1/NCT07387926/registered