EICHORCondition: Chronic Lymphocytic Leukemia · Sponsor: AbbVie
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Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical a…
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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Inclusion Criteria: * Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months. * Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. * Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion. Exclusion Criteria: \- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Arizona Oncology - Tucson - Rudasill /ID# 267552 | Tucson, Arizona, United States | Recruiting |
| Southern VA Health Care System /ID# 266254 | Tucson, Arizona, United States | Recruiting |
| UCSF FRESNO/Community Cancer Institute /ID# 270874 | Clovis, California, United States | Recruiting |
| Valkyrie Clinical Trials /ID# 268151 | Los Angeles, California, United States | Recruiting |
| Rocky Mountain Cancer Centers - Aurora /ID# 267549 | Aurora, Colorado, United States | Recruiting |
| Yale University School of Medicine /ID# 266224 | New Haven, Connecticut, United States | Recruiting |
| Malcolm Randall V.A. Medical Center /ID# 267825 | Gainesville, Florida, United States | Recruiting |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713 | Jacksonville, Florida, United States | Recruiting |
| Mid Florida Hematology And Oncology Center /ID# 269159 | Orange City, Florida, United States | Recruiting |
| Comprehensive Hematology Oncology /ID# 267644 | St. Petersburg, Florida, United States | Recruiting |
| Springfield Clinic - First /ID# 270145 | Springfield, Illinois, United States | Recruiting |
| Northwest Cancer Center - Dyer Clinic /ID# 268478 | Dyer, Indiana, United States | Recruiting |
+ 58 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06428019