Acalabrutinib for Chronic Lymphocytic Leukemia
(ASSURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of acalabrutinib, a medication for chronic lymphocytic leukemia (CLL), a type of blood cancer. The study includes three groups: those who have never received treatment, those whose cancer has returned or didn't respond to previous treatment, and those who have tried a specific previous medication called ibrutinib. People with active CLL symptoms, such as frequent fatigue or night sweats, and without certain other medical issues, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking proton-pump inhibitors and certain anticoagulants like warfarin at least 7 days before starting the study. If you're on these medications, you may need to switch to alternatives like H2-receptor antagonists or antacids.
Is there any evidence suggesting that acalabrutinib is likely to be safe for humans?
Research shows that acalabrutinib is generally safe for people with chronic lymphocytic leukemia (CLL). Studies have found that patients taking acalabrutinib had a lower risk of death compared to those using traditional chemoimmunotherapy treatments. Most people tolerate this medication well. Common side effects include headache and diarrhea, but these are usually mild.
In real-world use, outside strict clinical trials, acalabrutinib has proven effective, and its safety has remained consistent. This indicates it works well and is generally safe for many patients. While side effects can occur, they are usually manageable. Patients should always discuss any concerns with their doctor.12345Why do researchers think this study treatment might be promising for chronic lymphocytic leukemia?
Acalabrutinib is unique because it specifically targets Bruton's tyrosine kinase (BTK), a key player in the growth and survival of cancer cells in chronic lymphocytic leukemia (CLL). Unlike other treatments that may affect multiple pathways, acalabrutinib offers a more focused approach, potentially leading to fewer side effects. This precision targeting is what excites researchers, as it holds promise for improved outcomes and quality of life for patients with CLL, especially those who have relapsed or are refractory to other treatments like ibrutinib.
What evidence suggests that acalabrutinib might be an effective treatment for chronic lymphocytic leukemia?
Studies have shown that acalabrutinib works well in treating chronic lymphocytic leukemia (CLL). One study found that 95% of patients experienced a reduction in cancer symptoms. Another study reported that 83% of people taking acalabrutinib had no cancer growth or spread, compared to 56% with another treatment. These findings suggest that acalabrutinib can control the disease better than some other treatments. Real-world evidence also supports its effectiveness in treating CLL, offering significant benefits for patients. Participants in this trial will join different cohorts to further evaluate acalabrutinib's effectiveness in various CLL scenarios.12678
Who Is on the Research Team?
Adel Habib, MD
Principal Investigator
AstraZeneca
Dr. Carsten Niemann, MD
Principal Investigator
Rigshospitalet, Denmark
Are You a Good Fit for This Trial?
This trial is for adults with chronic lymphocytic leukemia (CLL) who are either untreated, have relapsed or are refractory to previous treatments, or have had prior ibrutinib therapy. Participants must show signs of progressive disease and meet specific blood cell count criteria. Pregnant women, individuals with recent malignancies other than CLL, those on certain medications like proton-pump inhibitors or strong CYP3A inhibitors/inducers, and patients with significant heart issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acalabrutinib 100 mg twice daily for up to 48 cycles (each cycle is 28 days)
Safety Follow-up
Safety follow-up visits occur approximately 30 days from the last dose of study treatment
Disease Follow-up
Participants who continue to derive benefit from treatment after 48 cycles will be followed every 24 weeks until study intervention discontinuation
What Are the Treatments Tested in This Trial?
Interventions
- Acalabrutinib
Acalabrutinib is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland