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This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
Safety and efficacy data through 13 October 2021 are included in the interim analysis, which was conducted after all participants completed the post-treatment Week 65 visit or discontinued from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
|
| Obinutuzumab/bendamustine | Experimental | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Administered via intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) | Low tumor burden is defined as absolute lymphocyte count (ALC) < 25 × 10^9 /L and all lymph nodes < 5 cm per computed tomography (CT) scans. | From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug |
| Complete Remission Rate | Complete remission rate is defined as the percentage of participants achieving complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following:
CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity. | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieved a best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) based on the 2008 Modified IWCLL NCI-WG criteria at any time during the study as assessed by investigator up through the completion of the 65-week disease response assessment after the start of venetoclax. Participants who did not respond were considered non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC-HOPE /ID# 202335 | Tempe | Arizona | 85284-1812 | United States | ||
| Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Flinn IW, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke JM, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Vizkelety T, Pesko J, Chyla B, Jiang D, Sharman JP. Debulking Before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study. American Society of Hematology - 63rd Annual Meeting. 2021 | ||
| Result | Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko D, Vizkelety T, Sharmokh S, Nielsen J, Flinn I. Phase 3b study to evaluate debulking regimens prior to initiating venetoclax therapy in untreated patients with chronic lymphocytic leukemia. Florida Society of Clinical Oncology-2020 Fall Session | ||
| Result | Flinn I, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko D, Vizkelety T, Sharmokh S, Sharman J. Debulking Regimens Prior To Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Interim Results from a Phase 3b Study. American Society of Hematology - 62nd Annual Meeting. 2020 | ||
| Result | Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko J, Vizkelety T, Sharmokh S, Nielsen J, Flinn I. Phase 3b Study to Evaluate Debulking Regimens Prior to Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia. Society of Hematologic Oncology-8th Annual Meeting. 2020 | ||
| Result | Sharman J, Andorsky D. Melear J, Manda S, Anz B II, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko J, Vizkelety T, Sharmkokh S, Nielsen J, Flinn I. Phase 3b study to evaluate debulking regimens prior to initiating venetoclax therapy in untreated patients with chronic lymphocytic leukemia. European Hematology Association-25th Congress. 2020 |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
All Treated Participants: all enrolled participants who received at least one dose of any study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
| 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 | Dec 19, 2019 | Oct 7, 2022 |
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| Bendamustine | Drug | Administered via intravenous infusion |
|
|
| Venetoclax | Drug | The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Venetoclax was continued for a total duration of up to 53 weeks, including the 5-week ramp-up schedule. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. |
|
|
| From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Duration of Response (DoR) | DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine). Duration of response was analyzed by Kaplan-Meier (K-M) methodology. | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Progression-Free Survival (PFS) | PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug. Progression-free survival was analyzed by Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Time to Progression (TTP) | TTP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.The distribution of the time to progression was estimated using Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Overall Survival (OS) | OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death. If a participant had not died, their data was censored at the date when they were last known to be alive prior to the cutoff date.The distribution of OS was estimated using Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
| Undetectable Minimal Residual Disease (UMRD) Rate | The level of MRD was assessed in the peripheral blood of all participants at 5 months after last dose of obinutuzumab, and at 3 months after last dose of venetoclax/end of treatment (including early study termination) to determine the rate of UMRD. Undetectable Minimal Residual Disease is defined as less than one CLL cell per 10,000 leukocytes (< 10^-4 ). | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021) |
| Denver |
| Colorado |
| 80218 |
| United States |
| MidAmerica Division, Inc. /ID# 201099 | Kansas City | Missouri | 64132 | United States |
| Oncology Hematology Care, Inc. /ID# 202397 | Cincinnati | Ohio | 45236-2725 | United States |
| Willamette Valley Cancer Institute and Research Center /ID# 201201 | Eugene | Oregon | 97401-6043 | United States |
| Prisma Health Cancer Inst - Eastside /ID# 202329 | Greenville | South Carolina | 29615 | United States |
| Tennessee Oncology - Chattanooga /ID# 202840 | Chattanooga | Tennessee | 37404-1108 | United States |
| Tennessee Oncology-Nashville Centennial /ID# 201098 | Nashville | Tennessee | 37203-1632 | United States |
| Texas Oncology - Austin Midtown /ID# 201199 | Austin | Texas | 78705 | United States |
| Texas Oncology - Beaumont /ID# 202359 | Beaumont | Texas | 77701-4691 | United States |
| Texas Oncology - Medical City Dallas /ID# 201196 | Dallas | Texas | 75230 | United States |
| Texas Oncology - McAllen /ID# 202331 | McAllen | Texas | 78503 | United States |
| Texas Oncology - San Antonio Medical Center /ID# 202332 | San Antonio | Texas | 78240-5251 | United States |
| Texas Oncology - Northeast Texas /ID# 201211 | Tyler | Texas | 75702 | United States |
| Northwest Cancer Specialists, P.C. /ID# 201198 | Vancouver | Washington | 98684 | United States |
| Result | Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Al Masud A, Zimmerman T, Nielsen J, Vizkelety T, Jiang D, Flinn I. Debulking eliminates need for hospitalization prior to initiating frontline venetoclax therapy in previously untreated CLL patients: a phase 3b study. American Society of Hematology - 61st Annual Meeting. 2019 |
| FG001 | Obinutuzumab/Bendamustine | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
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| NOT COMPLETED |
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All Treated Participants: all enrolled participants who received at least one dose of any study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
| BG001 | Obinutuzumab/Bendamustine | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 | |||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period) | Low tumor burden is defined as absolute lymphocyte count (ALC) < 25 × 10^9 /L and all lymph nodes < 5 cm per computed tomography (CT) scans. | Participants who completed debulking and were subsequently treated with venetoclax with available data | Posted | Number | percentage of participants | From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug |
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| Primary | Complete Remission Rate | Complete remission rate is defined as the percentage of participants achieving complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following:
CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity. | All treated participants who received at least 1 dose of any study drug | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieved a best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) based on the 2008 Modified IWCLL NCI-WG criteria at any time during the study as assessed by investigator up through the completion of the 65-week disease response assessment after the start of venetoclax. Participants who did not respond were considered non-responders. | All treated participants who received at least 1 dose of any study drug | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Duration of Response (DoR) | DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine). Duration of response was analyzed by Kaplan-Meier (K-M) methodology. | All treated participants who received at least 1 dose of any study drug and who had a record of first response (CR, CRi, PR, or nPR) | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Progression-Free Survival (PFS) | PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug. Progression-free survival was analyzed by Kaplan-Meier methodology. | All treated participants who received at least 1 dose of any study drug | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Time to Progression (TTP) | TTP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.The distribution of the time to progression was estimated using Kaplan-Meier methodology. | All treated participants who received at least 1 dose of any study drug | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Overall Survival (OS) | OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death. If a participant had not died, their data was censored at the date when they were last known to be alive prior to the cutoff date.The distribution of OS was estimated using Kaplan-Meier methodology. | All treated participants who received at least 1 dose of any study drug | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days |
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| Secondary | Undetectable Minimal Residual Disease (UMRD) Rate | The level of MRD was assessed in the peripheral blood of all participants at 5 months after last dose of obinutuzumab, and at 3 months after last dose of venetoclax/end of treatment (including early study termination) to determine the rate of UMRD. Undetectable Minimal Residual Disease is defined as less than one CLL cell per 10,000 leukocytes (< 10^-4 ). | All treated participants who received at least 1 dose of any study drug | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021) |
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All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time patients were followed was: 1183.0 days (Obinutuzumab Debulking); 1185.5 days (Obinutuzumab + Bendamustine Debulking); 1114.0 days (Obinutuzumab + Venetoclax Post-debulking); and 992.5 days (Venetoclax Monotherapy Post-debulking).
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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 | Obinutuzumab Debulking | Participants who received obinutuzumab during the debulking regimen period | 1 | 84 | 7 | 84 | 82 | 84 |
| EG001 | Obinutuzumab + Bendamustine Debulking | Participants who received obinutuzumab and bendamustine during the debulking regimen period | 0 | 36 | 3 | 36 | 35 | 36 |
| EG002 | Obinutuzumab + Venetoclax Post-debulking | Participants who received obinutuzumab and venetoclax during the post-debulking period | 1 | 117 | 15 | 117 | 105 | 117 |
| EG003 | Venetoclax Monotherapy Post-debulking | Participants who received venetoclax monotherapy during the post-debulking period; safety data were collected starting 30 days after the last dose of obinutuzumab | 10 | 114 | 13 | 114 | 90 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| ENDOMETRITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| MENINGITIS ASEPTIC | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| DRUG DISPENSED TO WRONG PATIENT | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
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| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| PROSTATE CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2023 | Jun 26, 2024 | SAP_002.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| C538045 | Chromosome 17 deletion |
| D015275 | Tumor Lysis Syndrome |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| 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 |
|---|---|
| C543332 | obinutuzumab |
| D000069461 | Bendamustine Hydrochloride |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian/Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Missing |
|
| From Baseline to the End of Cycle 4 |
|
|
| From Baseline to the End of Cycle 6 |
|
|
| OG001 | Obinutuzumab/Bendamustine | Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
|
|
Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
|
|
Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m^2 ) was to be administered to those with nodes or nodal mass > 10 cm, or with del(11q) and > 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. |
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