Trial · NCT02296918
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (OR) at 12 Months as Assessed by the Investigator in Cohorts 1 and 2 | Day 1 through 12 months | The OR is complete remission (CR), incomplete CR (CRi), nodular partial remission (nPR), or partial remission (PR) for at least 2 months. For CLL, CR:lymphocytes (lympho) \<4×10\^9/L, normocellular bone marrow (BM) \<30% lympho, no B-lymphoid nodules, normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophils (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL; CRi: lympho \<4×10\^9/L, hypocellular BM, NLN, L/S, persistent anemia/thrombocytopenia/neutropenia; nPR: CR with present lymphoid nodules (NL); PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (\<5×10\^9/L or \>=50% decrease from baseline), criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology without exogenous growth factors/transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1cm LN, no enlargement of L/S/NL, disease-free BM; PR: \>=50% decrease in dominant masses with no size increase/new lesions, and \>=50% reduction of nodules in S/L. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Primary | Number of Participants With Treatment-Emergent Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Abnormalities in Laboratory Parameters in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | Participants with treatment-emergent CTCAE Grade 3 or 4 abnormalities in laboratory parameters are reported. Laboratory analysis included hematology, clinical chemistry, and immunology. |
| Primary | Number of Participants With Abnormal Vital Signs Reported as TEAEs in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | Participants with abnormal vital signs (blood pressure, respiratory rate, heart rate, temperature, and body weight) reported as TEAEs are reported. |
| Primary | Number of Participants with Shift From Baseline to Worst (Grade 3 and 4) Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status in all Cohorts | Baseline (Days -28 to -1) through the final data cutoff date (approximately 6 years 8 months) | The ECOG Performance Status assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=death. Shift from baseline (Days -28 to -1) to worst Grade 3 and/4 in EOCG status are reported. |
| Secondary | Percentage of Participants with CR as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | For CLL, CR: lymphocytes \< 4×10\^9/L, normocellular bone marrow \< 30% lymphocytes, no B-lymphoid nodules, normal lymph nodes, liver and spleen, absolute neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, hemoglobin \> 11g/dL. Hematology without exogenous growth factors/ transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1 cm lymph nodes, no enlargement of liver/spleen/lymphoid nodules, disease-free bone marrow. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD)-negative CR as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | For CLL, CR: lymphocytes \<4×10\^9/L, normocellular bone marrow (BM) \<30% lymphocytes, no B-lymphoid nodules, normal lymph nodes, liver, and spleen, absolute neutrophil count \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin \> 11g/dL; CRi: lymphocytes \< 4×10\^9/L, hypocellular BM, normal lymph nodes, liver, and spleen, persistent anemia/thrombocytopenia/neutropenia. Hematology without exogenous growth factors/transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1 cm lymph nodes, no enlargement of liver/spleen/lymphoid nodules, disease-free BM. MRD negativity was determined in bone marrow by flow cytometry. |
| Secondary | Percentage of Participants With OR at Cycle 16 as Assessed by the Investigator in Cohorts 3 and 4 | Day 1 to the end of Cycle 16 (each cycle is 28 days) | The OR is complete remission (CR), incomplete CR (CRi), nodular partial remission (nPR), or partial remission (PR) for at least 2 months. For CLL, CR: lymphocytes \<4×10\^9/L, normocellular bone marrow \<30% lymphocytes, no B-lymphoid nodules, normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophils (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL; CRi: lymphocytes \<4×10\^9/L, hypocellular bone marrow, NLN, L/S, persistent anemia/thrombocytopenia/neutropenia; nPR: CR with present lymphoid nodules; PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lymphocytes (\<5×10\^9/L or \>=50% decrease from baseline), criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology without exogenous growth factors/transfusion. |
| Secondary | Duration of Response (DoR) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The DoR is defined as the time from the date of achieving the first CR, CRi, nPR, or PR (PR or better) to the date of progressive disease (PD) or death due to any cause, whichever occurred first. The CR, CRi, nPR, and PR are defined in the above outcome measure. For CLL, PD is defined as any one of the criteria: lymphocytes \>=50% increase from baseline, appearance of any new lesion or new hepatomegaly or splenomegaly or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, decrease of Hb levels \>2 g/dL or to \<10 g/dL, or decrease of platelets \>50% or to\<100,000/μL. For SLL, PD is defined as any one of the criteria: appearance of a new lesion \>1.5 cm in any axis; \>=50% increase in the products of at least 2 LNs; \>=50% increase in the longest diameter of a previously identified node \>1 cm in short axis; \>=50% increase in the size of the L and/or S or previously determined nodules in the L/S; or new or recurrent BM involvement. The DoR was estimated using Kaplan-Meier method. |
| Secondary | Progression Free Survival (PFS) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The PFS is defined as the time from the date of first dose of study drug to the date of first PD or death due to any cause, whichever occurred first. For CLL, PD is defined as any one of the criteria as: lymphocytes \>=50% increase from baseline, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, decrease of Hb levels \>2 g/dL or to \<10 g/dL, or decrease of platelets \>50% or to\<100,000/μL. For SLL, PD is defined as any one of the criteria as: appearance of a new lesion \>1.5 cm in any axis; \>=50% increase in the products of at least 2 LNs; \>=50% increase in the longest diameter of a previously identified node \>1 cm in short axis; \>=50% increase in the size of the L and/or S or previously determined nodules in the L/S; or new or recurrent BM involvement. The PFS was estimated using Kaplan-Meier method. |
| Secondary | Time to Next Treatment (TTNT) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The TTNT is defined as the time from the date of first dose of study drug to the date of institution of subsequent anticancer therapy for CLL or death due to any cause, whichever occurred first. The TTNT was estimated using Kaplan-Meier method. |
| Secondary | Overall Survival (OS) as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The OS is defined as the time from the date of first dose of study drug to death due to any cause or last follow-up. The OS was estimated using Kaplan-Meier method. |
| Secondary | Time to Initial PR or Better Response as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The time to initial PR or better response is defined as the time from the date of first dose of study drug to the date of first PR or better (ie, CRi or CR). For CLL, CR: lymphocytes (lympho) \<4×10\^9/L, normocellular bone marrow (BM) \<30% lympho, no B-lymphoid nodules, normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophils (ANC) \>1.5×10\^9/L, platelets \>100×10\^9/L, hemoglobin (Hb) \>11g/dL; CRi: lympho \<4×10\^9/L, hypocellular BM, NLN, L/S, persistent anemia/thrombocytopenia/neutropenia; PR: \>=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (\<5×10\^9/L or \>=50% decrease from baseline), criteria of ANC/platelets/Hb per CR or \>=50% improvement over baseline. Hematology without exogenous growth factors/transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1cm LN, no enlargement of L/S/NL, disease-free BM; PR: \>=50% decrease in dominant masses with no size increase/new lesions, and \>=50% reduction of nodules in S/L. |
| Secondary | Time to Initial CR as Assessed by the Investigator in all Cohorts | Day 1 through the final data cutoff date (approximately 6 years 8 months) | The time to initial CR is defined as the time from the date of first dose of study drug to the date of first CR. For CLL, CR: lymphocytes \< 4×10\^9/L, normocellular bone marrow \< 30% lymphocytes, no B-lymphoid nodules, normal lymph nodes, liver and spleen, absolute neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, hemoglobin \> 11g/dL. Hematology without exogenous growth factors/ transfusion. For SLL, CR: no disease/disease-related symptoms, normal/\<=1 cm lymph nodes, no enlargement of liver/spleen/lymphoid nodules, disease-free bone marrow. |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib and its Metabolite ACP-5862 in Cohorts 1, 3, and 4 | During Cohort 1: pre-dose; 0.5, 1, 2, 3, 4, 6, and 24 hours post-dose for Cycle 1. Cohorts 3 and 4: pre-dose; 0.5, 1, 2, 3, 4, 6, and 24 hours post-dose for Cycles 1, 3, and 5. (each cycle is 28 days) | The Tmax of acalabrutinib and its metabolite ACP-5862 are reported. |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Venetoclax in Cohorts 3 and 4 | Predose and at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose on Cycle 3 Day 1 and Cycle 5 Day 1. (each cycle is 28 days). | The Tmax of venetoclax is reported. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib and its Metabolite ACP-5862 in Cohorts 1, 3, and 4 | Cohort 1: pre-dose; 0.5, 1, 2, 3, 4, 6, and 24 hours post-dose for Cycle 1. Cohorts 3 and 4: pre-dose; 0.5, 1, 2, 3, 4, 6, and 24 hours post-dose for Cycles 1, 3, and 5. (each cycle is 28 days) | The Cmax of acalabrutinib and ACP-5862 are reported. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Venetoclax in Cohorts 3 and 4 | Predose and at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose on Cycle 3 Day 1 and Cycle 5 Day 1. (each cycle is 28 days) | The Cmax of venetoclax is reported. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib in Cohort 1 | Pre-dose; 0.5, 1, 2, 3, 4, and 6 hours post-dose for Cycle 1. (each cycle is 28 days) | The AUC0-6 of acalabrutinib is reported. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Venetoclax in Cohorts 3 and 4 | Predose and at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose on Cycle 3 Day 1 and Cycle 5 Day 1. (each cycle is 28 days) | The AUC0-6 of venetoclax is reported. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02296918/registered