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This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acalabrutinib | Experimental | Acalabrutinib will be orally administered until disease progression or unacceptable toxicity |
|
| Rituximab and Chlorambucil | Active Comparator | Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acalabrutinib | Drug | acalabrutinib 100 mg twice daily orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Assessed by BICR | PFS was defined as the time from randomization to PD (assessed by BICR according to International Workshop on Chronic Lymphocytic Leukaemia [iwCLL] 2018 guideline criteria) or death due to any cause. PD was defined as meeting at least 1 of the below criteria of groups(g) A or B. gA: increase of ≥50% from baseline (BL) or from response in lymph nodes or liver and/or spleen size; any constitutional symptoms; increase of ≥50% over nadir with absolute count ≥ 5×10^9/liter (L) in circulating lymphocyte count (CLC); gB: decrease of ≥50% from BL secondary to CLL in platelet count; decrease of ≥2 gram per deciliter (g/dL) from BL secondary to CLL in hemoglobin (Hb); increase of CLL cells by ≥50% on successive biopsies in bone marrow (BM). Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Assessed by BICR and Investigator | ORR:percentage of participants with complete response(CR),CR with incomplete BM recovery(CRi), partial response(PR)/nodular PR(nPR) assessed by BICR;investigator per IWCLL 2018 criteria at/before initiation of subsequent anti-cancer therapy.CR:No lymph nodes(target lesions)≥1.5 centimeter(cm), spleen<13cm,normal liver;CLC,no constitutional symptoms,platelets≥100,000/microliter(μL),Hb≥11.0 g/dL,BM:normocellular,no CLL cells&B-lymphoid nodules.PR:atleast 2 gA parameters;1 gB parameter need to improve if previously abnormal.If only 1 parameter of both gA,B was abnormal prior to therapy,only 1 needs to improve.gA:Decrease≥50% from BL in lymph nodes,liver & or spleen size,CLC;any constitutional symptoms, gB:platelet≥100,000/μL or increase 50% over BL;Hb≥11g/dL or increase≥50% over BL;BM:presence of CLL cells/B-lymphoid nodules/not done.CRi:all CR criteria+persistent anemia,thrombocytopenia or neutropenia unrelated to CLL,related to drug toxicity.nPR:CR+presence of B-lymphoid nodules in BM. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence (other than progression of the malignancy under evaluation) in participant or clinical study participant administered medicinal product and which does not necessarily had a causal relationship with treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was life-threatening, required in-participant hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred or worsened in severity on or after date of the first dose of study drug up to 30 days after last dose of study drug or prior to initiation of a new anti-CLL therapy, whichever occurred first. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu, MD | Chinese Academy of Medical Science Affiliated Hospital of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100191 | China | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| CSR synopsis | View source |
| Related Info | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
A total of 155 participants were randomized in 1:1 ratio to acalabrutinib treatment arm or chlorambucil plus rituximab treatment arm. All participants should receive the same dose within their respective treatment arms.
This Phase III, multicenter, randomized, open-label study was conducted in participants with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation at 46 sites across 5 countries. Results are presented up to data cut-off (DCO) date of 03 January 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acalabrutinib | Participants received acalabrutinib 100 milligram (mg) orally twice daily (BID) in 28-day cycles until progression of disease (PD) or any other treatment discontinuation criterion was met. |
| FG001 | Chlorambucil Plus Rituximab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2024 | Dec 23, 2024 |
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| Rituximab |
| Drug |
Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6) |
|
| Chlorambucil | Drug | Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6 |
|
| Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Duration of Response (DOR) Assessed by BICR and Investigator | DOR was defined as the time from response (date of first documented response) to PD or death (absence of PD) as judged by BICR and investigator. PD was defined as meeting at least 1 of the below criteria of group A or group B. Group A: Increase of ≥ 50% from BL or from response in lymph nodes or liver and/or spleen size; any constitutional symptoms; increase of ≥50% over nadir with absolute count ≥ 5×10^9/L in CLC; group B: decrease of ≥50% from BL secondary to CLL in platelet count; decrease of ≥2 g/dL from BL secondary to CLL in hemoglobin; increase of CLL cells by ≥50% on successive biopsies in marrow. Median DOR was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Time to Next Treatment (TTNT) | TTNT was defined as the time from the date of randomization to the date of initiation of non-protocol-specified anti-CLL therapy (either medication or radiotherapy for CLL) or death from any cause, whichever occurred first. Median TTNT was calculated using Kaplan-Meier method and its CI was calculated using Brookmeyer-Crowley method. | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD, and survival follow-ups performed every 12 weeks thereafter, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Overall Survival (OS) | OS was defined as the time from the date of randomization until death due to any cause. The median OS was calculated using Kaplan-Meier method and its CI was calculated using Brookmeyer-Crowley method. | From date of randomization until death due to any cause, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Minimal Residual Disease (MRD) Negativity Rate | The MRD negative rate was defined as the percentage of participants with MRD-negativity (defined as <1 CLL cell per 10,000 leukocytes) measured in the peripheral blood by flow cytometry. | At Cycle 9 (cycle duration: 28 days) |
| Plasma Concentrations of Acalabrutinib and Its Metabolite ACP-5862 | Blood samples were collected to determine the concentration of acalabrutinib and its metabolite ACP-5862 in plasma. | Pre-dose, and at 1, 2, 4 hours post-dose on Day 1 of Cycle 2 (cycle duration: 28 days) |
| From first dose of study drug (Day 1) up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
| Changchun |
| 130021 |
| China |
| Research Site | Changsha | 410013 | China |
| Research Site | Changzhou | 272100 | China |
| Research Site | Guangzhou | 510100 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Guiyang | 550004 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hefei | 230001 | China |
| Research Site | Hefei | 230031 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Qingdao | 110016 | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200040 | China |
| Research Site | Shanghai | 200050 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Shijiazhuang | 050020 | China |
| Research Site | Suzhou | 215006 | China |
| Research Site | Taiyuan | 030001 | China |
| Research Site | Tianjin | 300020 | China |
| Research Site | Xuzhou | 221000 | China |
| Research Site | Zhengzhou | 450008 | China |
| Research Site | Zhengzhou | 450052 | China |
| Research Site | Baguio City | 2600 | Philippines |
| Research Site | Cebu | 6000 | Philippines |
| Research Site | Davao City | 8000 | Philippines |
| Research Site | Makati | 1229 | Philippines |
| Research Site | Manila | 1000 | Philippines |
| Research Site | Quezon City | 1112 | Philippines |
| Research Site | Chiayi City | 613 | Taiwan |
| Research Site | Hualien City | 97002 | Taiwan |
| Research Site | Kaohsiung City | 833 | Taiwan |
| Research Site | Taichung | 404 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Bangkok | 10400 | Thailand |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Chiang Mai | 50200 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Khon Kaen | 40002 | Thailand |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Related Info | View source |
Participants received chlorambucil 0.5 milligram per kilogram (mg/kg) body weight orally on Day 1 and Day 15 of all 28-day treatment cycles (Cycles 1 to 6) along with an intravenous (IV) infusion of rituximab 375 milligram per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of each subsequent cycles (Cycles 2 to 6). Cycle duration=28 days. Participants received 6 cycles of chlorambucil plus rituximab or until PD or any other treatment discontinuation criterion was met. |
| Safety Analysis Set (SAS) | SAS included all participants who received at least 1 dose of study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set (FAS) included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acalabrutinib | Participants received acalabrutinib 100 mg orally BID in 28-day cycles until PD or any other treatment discontinuation criterion was met. |
| BG001 | Chlorambucil Plus Rituximab | Participants received chlorambucil 0.5 mg/kg body weight orally on Day 1 and Day 15 of all 28-day treatment cycles (Cycles 1 to 6) along with an IV infusion of rituximab 375 mg/m^2 on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of each subsequent cycles (Cycles 2 to 6). Cycle duration=28 days. Participants received 6 cycles of chlorambucil plus rituximab or until PD or any other treatment discontinuation criterion was met. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Assessed by BICR | PFS was defined as the time from randomization to PD (assessed by BICR according to International Workshop on Chronic Lymphocytic Leukaemia [iwCLL] 2018 guideline criteria) or death due to any cause. PD was defined as meeting at least 1 of the below criteria of groups(g) A or B. gA: increase of ≥50% from baseline (BL) or from response in lymph nodes or liver and/or spleen size; any constitutional symptoms; increase of ≥50% over nadir with absolute count ≥ 5×10^9/liter (L) in circulating lymphocyte count (CLC); gB: decrease of ≥50% from BL secondary to CLL in platelet count; decrease of ≥2 gram per deciliter (g/dL) from BL secondary to CLL in hemoglobin (Hb); increase of CLL cells by ≥50% on successive biopsies in bone marrow (BM). Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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| Secondary | Overall Response Rate (ORR) Assessed by BICR and Investigator | ORR:percentage of participants with complete response(CR),CR with incomplete BM recovery(CRi), partial response(PR)/nodular PR(nPR) assessed by BICR;investigator per IWCLL 2018 criteria at/before initiation of subsequent anti-cancer therapy.CR:No lymph nodes(target lesions)≥1.5 centimeter(cm), spleen<13cm,normal liver;CLC,no constitutional symptoms,platelets≥100,000/microliter(μL),Hb≥11.0 g/dL,BM:normocellular,no CLL cells&B-lymphoid nodules.PR:atleast 2 gA parameters;1 gB parameter need to improve if previously abnormal.If only 1 parameter of both gA,B was abnormal prior to therapy,only 1 needs to improve.gA:Decrease≥50% from BL in lymph nodes,liver & or spleen size,CLC;any constitutional symptoms, gB:platelet≥100,000/μL or increase 50% over BL;Hb≥11g/dL or increase≥50% over BL;BM:presence of CLL cells/B-lymphoid nodules/not done.CRi:all CR criteria+persistent anemia,thrombocytopenia or neutropenia unrelated to CLL,related to drug toxicity.nPR:CR+presence of B-lymphoid nodules in BM. | FAS included all randomized participants. | Posted | Number | percentage of participants | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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| Secondary | Duration of Response (DOR) Assessed by BICR and Investigator | DOR was defined as the time from response (date of first documented response) to PD or death (absence of PD) as judged by BICR and investigator. PD was defined as meeting at least 1 of the below criteria of group A or group B. Group A: Increase of ≥ 50% from BL or from response in lymph nodes or liver and/or spleen size; any constitutional symptoms; increase of ≥50% over nadir with absolute count ≥ 5×10^9/L in CLC; group B: decrease of ≥50% from BL secondary to CLL in platelet count; decrease of ≥2 g/dL from BL secondary to CLL in hemoglobin; increase of CLL cells by ≥50% on successive biopsies in marrow. Median DOR was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | FAS included all randomized participants. Only participants with response in each specified category were analyzed in this outcome measure. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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| Secondary | Time to Next Treatment (TTNT) | TTNT was defined as the time from the date of randomization to the date of initiation of non-protocol-specified anti-CLL therapy (either medication or radiotherapy for CLL) or death from any cause, whichever occurred first. Median TTNT was calculated using Kaplan-Meier method and its CI was calculated using Brookmeyer-Crowley method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD, and survival follow-ups performed every 12 weeks thereafter, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization until death due to any cause. The median OS was calculated using Kaplan-Meier method and its CI was calculated using Brookmeyer-Crowley method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From date of randomization until death due to any cause, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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| Secondary | Minimal Residual Disease (MRD) Negativity Rate | The MRD negative rate was defined as the percentage of participants with MRD-negativity (defined as <1 CLL cell per 10,000 leukocytes) measured in the peripheral blood by flow cytometry. | FAS included all randomized participants. | Posted | Number | percentage of participants | At Cycle 9 (cycle duration: 28 days) |
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| Secondary | Plasma Concentrations of Acalabrutinib and Its Metabolite ACP-5862 | Blood samples were collected to determine the concentration of acalabrutinib and its metabolite ACP-5862 in plasma. | Pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of study drug, for whom there was at least 1 reportable post-dose PK concentration available. Only participants with data collected for each specified timepoints are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose, and at 1, 2, 4 hours post-dose on Day 1 of Cycle 2 (cycle duration: 28 days) |
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| Other Pre-specified | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence (other than progression of the malignancy under evaluation) in participant or clinical study participant administered medicinal product and which does not necessarily had a causal relationship with treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was life-threatening, required in-participant hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred or worsened in severity on or after date of the first dose of study drug up to 30 days after last dose of study drug or prior to initiation of a new anti-CLL therapy, whichever occurred first. | SAS included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug (Day 1) up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) |
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From first dose of study drug (Day 1) up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months).
SAS included all participants who received at least 1 dose of study treatment. All-cause mortality was reported in FAS. All participants should receive the same dose within their respective treatment arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acalabrutinib | Participants received acalabrutinib 100 mg orally BID in 28-day cycles until PD or any other treatment discontinuation criterion was met. | 2 | 77 | 30 | 77 | 67 | 77 |
| EG001 | Chlorambucil Plus Rituximab | Participants received chlorambucil 0.5 mg/kg bodyweight orally on Day 1 and Day 15 of all 28-day treatment cycles (Cycles 1 to 6) along with an IV infusion of rituximab 375 mg/m^2 on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of each subsequent cycles (Cycles 2 to 6). Cycle duration=28 days. Participants received 6 cycles of chlorambucil plus rituximab or until PD or any other treatment discontinuation criterion was met. | 5 | 78 | 17 | 73 | 61 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Salmonellosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Fournier's gangrene | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Lymphocyte count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2023 | Dec 23, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604908 | acalabrutinib |
| D000069283 | Rituximab |
| D002699 | Chlorambucil |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| White |
|
| Non-Hispanic or Latino |
|
Participants received chlorambucil 0.5 mg/kg body weight orally on Day 1 and Day 15 of all 28-day treatment cycles (Cycles 1 to 6) along with an IV infusion of rituximab 375 mg/m^2 on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of each subsequent cycles (Cycles 2 to 6). Cycle duration=28 days. Participants received 6 cycles of chlorambucil plus rituximab or until PD or any other treatment discontinuation criterion was met. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Participants received chlorambucil 0.5 mg/kg body weight orally on Day 1 and Day 15 of all 28-day treatment cycles (Cycles 1 to 6) along with an IV infusion of rituximab 375 mg/m^2 on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of each subsequent cycles (Cycles 2 to 6). Cycle duration=28 days. Participants received 6 cycles of chlorambucil plus rituximab or until PD or any other treatment discontinuation criterion was met. |
|
|