Study on Acalabrutinib, Obinutuzumab, and Chlorambucil for Untreated Chronic Lymphocytic Leukemia (CLL)
Sponsor: Acerta Pharma BV
ClinicalTrials ID:NCT02475681
This clinical trial is comparing different combinations of medications to see which is most effective for patients with chronic lymphocytic leukemia (CLL) who have not received treatment before. The study looks at how well these treatments work in controlling the disease and improving patient outcomes.
Patient Parameters
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Program Overview
The main goal of this study is to compare the effectiveness of two different treatment combinations for patients with chronic lymphocytic leukemia (CLL) who have not been treated before. One group receives Obinutuzumab with Chlorambucil, while another group receives Acalabrutinib with Obinutuzumab. The study also evaluates how well Acalabrutinib works on its own. Researchers are looking at how long patients live without the disease getting worse and other important outcomes like overall survival and time until the next treatment is needed.
Description
This study, called ELEVATE-TN, is a large, international research project involving patients with chronic lymphocytic leukemia (CLL) who have not received any prior treatment. The study enrolled 535 participants across 18 countries. Participants were randomly assigned to one of three groups: one group received Acalabrutinib and Obinutuzumab, another received Acalabrutinib alone, and the third group received Obinutuzumab with Chlorambucil. The main focus was to see how long patients could go without their disease getting worse when treated with these combinations. If patients' disease progressed on the Obinutuzumab-Chlorambucil combination, they could switch to Acalabrutinib. The study aims to provide new insights into effective treatments for CLL, especially for those who have not been treated before. The study is ongoing, with many participants still being monitored to gather more information.
Eligibility Criteria
Exclusion Criteria
- Previous treatment for CLL, except for localized radiotherapy.
- Known central nervous system (CNS) lymphoma or leukemia.
- History or suspicion of Richter's syndrome or prolymphocytic leukemia.
- Missing documentation of specific genetic test results before starting the study.
- Uncontrolled autoimmune conditions affecting blood cells.
- Recent use of high-dose steroids, except for certain medical conditions.
- Major surgery within four weeks before starting the study.
- History of other cancers, unless treated and inactive for over three years.
- Significant heart disease or recent heart attack.
- Difficulty swallowing pills or certain digestive conditions.
- Active infections or recent serious infections.
- History of HIV infection.
- Recent vaccination with live vaccines.
- Active hepatitis B or C infection.
- Recent stroke or brain bleeding.
- Known bleeding disorders.
- Use of certain blood thinners or medications affecting stomach acid.
- Pregnant or breastfeeding women.
- Serious medical conditions that could affect safety or study results.
- Participation in another clinical trial.
- Use of certain medications that interact with the study drugs.
- Recent diagnosis of a stomach ulcer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85395 | Goodyear | Arizona |
| Research Site | 85016 | Phoenix | Arizona |
| Research Site | 92801 | Anaheim | California |
| Research Site | 90017 | Los Angeles | California |
| Research Site | 90033 | Los Angeles | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 93030 | Oxnard | California |
| Research Site | 94304 | Palo Alto | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 80124 | Lone Tree | Colorado |
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