Trial · NCT04501614
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy | Up to Day 35 in Phase 1 | The RP2D is the maximum tolerated dose (MTD) or less. |
| Primary | Phase 2: Percentage of Participants With Complete Remission (CR) at the End of the Reinduction Block | Up to Day 35 in Phase 2 | CR was defined as no circulating blasts and less than (\<)5 percent (%) blasts in the bone marrow (BM); normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) greater than (\>)1000 cells/microliter (μL) (or \>1.0 × 10\^9 cells/liter \[L\]); Platelets \>100,000/μL (or \>100 × 10\^9 platelets/L). |
| Secondary | Phase 1: Number of Participants With CR at the End of Reinduction Block | Day 35 in Phase 1 | CR was defined as no circulating blasts and \<5% blasts in the BM; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000/μL (or \>100 × 10\^9 platelets/L). |
| Secondary | Phase 2: Percentage of Ph+ ALL Participants Who Achieved CR at the End of Consolidation Block | Day 70 in Phase 2 | CR was defined as no circulating blasts and \<5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000 platelets/μL (or \>100 × 10\^9 platelets/L). |
| Secondary | Phase 2: Percentage of Ph+ ALL Participants With Negative Minimal Residual Disease (MRD) Among Those Who Achieved CR | Up to Day 70 (end of consolidation block) in Phase 2 | MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate at \<0.01% threshold. |
| Secondary | Phase 2: Percentage of Participants Who Relapsed or Progressed Following Reinduction and Consolidation | Up to 3 years of follow-up in Phase 2 | |
| Secondary | Phase 2: Event-free Survival (EFS) | Up to 3 years of follow-up in Phase 2 | EFS was defined as time from date of enrollment until death due to any cause; refractory to treatment (defined as failure to achieve CR by end of the consolidation block) or relapse from CR. CR was defined as no circulating blasts and \<5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000 platelets/μL (or \>100 × 10\^9 platelets/L). |
| Secondary | Phase 2: Progression-free Survival (PFS) | Up to 3 years of follow-up in Phase 2 | PFS was defined as time from date of enrolment until death related to disease under study; disease progression (clinical deterioration associated with disease process, including evidence of increasing blasts in the bone marrow from baseline and/or evidence of new organ involvement) or relapse from CR. CR was defined as no circulating blasts and \<5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000 platelets/μL (or \>100 × 10\^9 platelets/L). |
| Secondary | Phase 2: Overall Survival (OS) | Up to 3 years of follow-up in Phase 2 | OS was defined as time from first dose of ponatinib until death due to any cause. |
| Secondary | Phase 2: Duration of Response (DOR) | Up to 3 years of follow-up in Phase 2 | DOR was defined as the interval between the first assessment at which the criteria for CR are met until the time at which relapse from CR occurs. CR was defined as no circulating blasts and \<5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000 platelets/μL (or \>100 × 10\^9 platelets /L). |
| Secondary | Phase 2: Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplantation (HSCT) | Up to 3 years of follow-up in Phase 2 | |
| Secondary | Phase 1: Cmax: Maximum Observed Plasma Concentration for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | |
| Secondary | Phase 1: Tmax: Time of First Occurrence of Cmax for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | |
| Secondary | Phase 1: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ponatinib | Predose and at multiple timepoints post-dose up to 24 hours on Days 1 and 22 in Phase 1 | |
| Secondary | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Venous Thrombotic/Embolic Events (VTEs), and Adverse Events of Special Interest (AESIs) | Up to 34.8 months in Phase 1 | An adverse event (AE) is defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not occurrence was considered related to the study intervention including any unfavorable \& unintended sign (e.g., clinically significant abnormal laboratory finding), symptom/disease. TEAE: any AE that occurs after administration of first dose of any study drug \& through 30 days after last dose of any study drug. Serious TEAE:AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability or incapacity, was congenital anomaly/birth defect, was medically important event. AESI: Protocol-defined AEs resulting in compromise of organ function or other significant consequences. VTEs were identified as AESIs for ponatinib and included arterial, VTEs that meet criteria for serious TEAEs. |
| Secondary | Phase 2: Number of Participants With TEAEs, Serious TEAEs, VTEs, and AESIs | Up to 30 days after last dose of ponatinib in Phase 2 | An AE is defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not occurrence was considered related to the study intervention including any unfavorable \& unintended sign (e.g., clinically significant abnormal laboratory finding), symptom/disease. TEAE: any AE that occurs after administration of first dose of any study drug \& through 30 days after last dose of any study drug. Serious TEAE:AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability or incapacity, was congenital anomaly/birth defect, was medically important event. AESI: Protocol-defined AEs resulting in compromise of organ function or other significant consequences. VTEs were identified as AESIs for ponatinib and included arterial, VTEs that meet criteria for serious TEAEs. |
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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