Trial · NCT03181126
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 | Cmax of Venetoclax + Navitoclax | Up to approximately 9 months | Maximum observed plasma concentration (Cmax) of venetoclax + navitoclax |
| Primary | AUC of Venetoclax + Navitoclax | Up to approximately 9 months | Area under the plasma concentration-time curve (AUC) of venetoclax + navitoclax |
| Primary | Tmax of Venetoclax + Navitoclax | Up to approximately 9 months | Time to Cmax (Tmax) of Venetoclax + Navitoclax |
| Primary | CL/F of Venetoclax + Navitoclax | Up to approximately 9 months | Apparent oral clearance (CL/F) of venetoclax + navitoclax |
| Primary | Number of participants with dose-limiting toxicities (DLT) | Up to approximately 28 days after initial dose of study drug | A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol. AEs and toxicities that occur beyond the DLT assessment period will also be evaluated by the investigator and AbbVie and may be considered as dose-limiting. |
| Secondary | Progression-free survival (PFS) | Up to 9 months after the last subject has enrolled into the study | PFS is defined as the number of days from the date of enrollment to the date of earliest disease progression or death. |
| Secondary | Partial Response (PR) rate | Up to 9 months after the last subject has enrolled into the study | PR defined as no peripheral blasts or peripheral blood absolute blast count decreased by ≥ 50% from baseline, bone marrow with 5 - 25% blasts and at least a 50% decrease in bone marrow blast percent from baseline, no evidence of extramedullary disease. |
| Secondary | Number of Participant who Proceed to Stem Cell Transplantation or Chimeric antigen receptor T-cell (CAR-T) Therapy | Up to 9 months after the last subject has enrolled into the study | Determine the number of participants who proceed to stem cell transplantation or CAR-T therapy. |
| Secondary | Overall survival (OS) | Up to 9 months after the last subject has enrolled into the study | OS is defined as the number of days from the date of enrollment to the date of death. |
| Secondary | Objective response rate (ORR) | Up to 9 months after the last subject has enrolled into the study | The proportion of subjects with objective response rate (complete response \[CR\] + CR incomplete recovery \[CRi\] + CR without platelet recovery \[CRp\]) for ALL subjects and (CR+PR) for LL subjects. |
| Secondary | Complete Response (CR) rate | Up to 9 months after the last subject has enrolled into the study | CR defined as hematologic recovery (absolute neutrophil count \[ANC\] greater than or equal to 500/μL; platelet counts greater than or equal to 75,000/μL), evidence of trilineage hematopoiesis in the bone marrow and less than 5% blasts in the bone marrow, absence of circulating blasts, and no evidence of extramedullary disease. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03181126/registered