Acalabrutinib + Obinutuzumab + Chlorambucil for Chronic Lymphocytic Leukemia
(ElevateTN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different drug combinations to determine the most effective treatment for chronic lymphocytic leukemia (CLL), a type of blood cancer. Researchers compare three treatments: one with obinutuzumab (Gazyva) and chlorambucil, another with acalabrutinib (Calquence) and obinutuzumab, and a third with only acalabrutinib. The trial seeks participants who have not received prior treatment and have active CLL impacting their daily life, such as fatigue or unintentional weight loss. Joining this study may help identify a better way to treat CLL. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require certain medications like proton-pump inhibitors or strong CYP3A inhibitors/inducers. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both acalabrutinib and obinutuzumab are generally well-tolerated by patients with chronic lymphocytic leukemia (CLL). Studies have found that acalabrutinib is safer than traditional chemoimmunotherapy, particularly regarding heart-related side effects.
When combined, acalabrutinib and obinutuzumab are safe for most patients, with side effects that are usually manageable. These can include mild issues like headaches and tiredness, while more serious side effects are less common but possible.
Chlorambucil, used in another treatment option, has a long history in cancer treatment. It can cause side effects like low blood cell counts and nausea, but these are often manageable.
Overall, previous research and real-world patient experiences have shown these treatments to be safe. However, potential participants should discuss any concerns with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Most treatments for Chronic Lymphocytic Leukemia (CLL), like ibrutinib or rituximab, work by targeting specific proteins on cancer cells to stop their growth. But acalabrutinib, included in this study, works differently by more selectively inhibiting the Bruton's tyrosine kinase (BTK) enzyme, potentially leading to fewer side effects and better patient tolerance. The combination of obinutuzumab, a monoclonal antibody, with chlorambucil or acalabrutinib provides a potent approach to attacking cancer cells from multiple angles, aiming to enhance efficacy. Researchers are excited about these treatments because they offer new hope for improved patient outcomes and quality of life by possibly reducing toxicity and increasing effectiveness against CLL.
What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?
Research has shown that acalabrutinib, one of the treatments in this trial, is very effective in treating chronic lymphocytic leukemia (CLL) when used alone. In one study, 92% of patients who received acalabrutinib and immunotherapy experienced no cancer growth, compared to 47% of those who received traditional treatments. In this trial, some participants will receive acalabrutinib alone, while others will receive it in combination with obinutuzumab. The combination of acalabrutinib with obinutuzumab has also shown promise. Specifically, this combination improved survival rates and was more effective in preventing cancer progression than acalabrutinib alone. A study found that this combination had an 87% rate of patients living without cancer progression for 48 months. These findings suggest that both acalabrutinib alone and in combination with obinutuzumab could be effective options for treating CLL.12678
Who Is on the Research Team?
AstraZeneca Clinical Study Information Center
Principal Investigator
1-877-240-9479 information.center@astrazeneca.com
Are You a Good Fit for This Trial?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL). Participants must be over 18, have a certain level of kidney function, and not have had previous systemic treatments for CLL. They should also meet specific health criteria like a particular white blood cell count and organ function. Women who can become pregnant and men who can father children must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with Acalabrutinib and Obinutuzumab, Acalabrutinib monotherapy, or Obinutuzumab and Chlorambucil over 6 cycles
Maintenance
Participants continue on study to generate more evidence, with more than 430 subjects currently in this phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acalabrutinib
- Chlorambucil
- Obinutuzumab
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?
Acerta Pharma BV
Lead Sponsor