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The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.
The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Added to cBTKi (Commercially Prescribed) | Experimental | Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (< 10^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Venetoclax tablets will be administered as per the schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| uMRD4 Rate at EOCT | uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10^-4) from PB. | Cycle 12 Day 28 (Cycle length= 28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| CR/CRi Rate at EOCT as Determined by the Investigator According to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines | Complete response (CR)/complete response with incomplete recovery of the bone marrow (CRi) rate is defined as the percentage of participants with a CR or CRi at EOCT, as determined by the investigator according to the iwCLL. | Up to approximately 12 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| Rocky Mountain Cancer Centers (Aurora) - USOR |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| cBTKi Monotherapy | Drug | Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label. |
|
| PR Rate at EOCT as Determined by the Investigator According to iwCLL Guidelines | PR rate is defined as the percentage of participants with a PR at EOCT, as determined by the investigator according to the iwCLL. | Up to approximately 12 months |
| Overall Response Rate (ORR) at EOCT as Determined by the Investigator According to iwCLL Guidelines | ORR is defined as the percentage of participants with a CR/CRi or PR at EOCT, as determined by the investigator according to the iwCLL. | Up to approximately 12 months |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE and SAEs will be collected as part of this study at baseline and every clinical visit, until 30 days after the final dose of study treatment. | Up to approximately 13 months |
| Number of Participants Who Withdrew Prematurely from the Study | Participants who discontinued treatment before Cycle 12 Day 28 (cycle length= 28 days). | Up to approximately 12 months |
| Overall Survival (OS) | OS is defined as the time from the first study treatment to death from any cause. | Up to approximately 48 months |
| Progression-free Survival (PFS) as Determined by the Investigator According to iwCLL Guidelines | PFS is defined as the time from the first study treatment to the first occurrence of disease progression (PD) or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL. | Up to approximately 48 months |
| Event-free Survival (EFS) as Determined by the Investigator According to iwCLL Guidelines | EFS is defined as the time from the first study treatment to the first occurrence of PD, anti-leukemic treatment subsequent to the study treatment, or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL. | Up to approximately 48 months |
| Duration of Response (DOR) in Participants With CR/CRi or PR as Determined by the Investigator According to iwCLL Guidelines | DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR/CRi or PR) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL. | Up to approximately 12 months |
| DOR in Participants With CR or CRi as Determined by the Investigator According to iwCLL Guidelines | DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR or CRi ) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL. | Up to approximately 12 months |
| Time to Next CLL Treatment (TTNT) | TTNT is defined as the time from the first study treatment to the start of anti-leukemic treatment subsequent to the study treatment or death, whichever occurs first. | Up to approximately 12 months |
| Aurora |
| Colorado |
| 80012-5405 |
| United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256-6932 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc | Fort Wayne | Indiana | 46804 | United States |
| Mission Blood and Cancer - MercyOne Cancer Center | Des Moines | Iowa | 50314-3030 | United States |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817-1915 | United States |
| Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center | Boston | Massachusetts | 02215-5418 | United States |
| Nebraska Cancer Specialists St Francis - Grand Island | Grand Island | Nebraska | 68803 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130-2042 | United States |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | 08816-4096 | United States |
| San Juan Oncology Associates, PC | Farmington | New Mexico | 87401 | United States |
| Oncology Hematology Care Inc - Cincinnati - USOR | Cincinnati | Ohio | 45236-2725 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401-6043 | United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504-8332 | United States |
| Tennessee Oncology, PLLC - Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology - Midtown | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology- Northeast Texas | Tyler | Texas | 75702 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 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 |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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