Acalabrutinib for Treating Patients with Mantle Cell Lymphoma Who Cannot Tolerate Ibrutinib
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT04189757
This study is testing how well the drug acalabrutinib works for patients with mantle cell lymphoma who cannot tolerate ibrutinib. Acalabrutinib may help stop cancer cell growth by blocking certain enzymes needed for cell growth.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This phase II trial is exploring the effectiveness of acalabrutinib in patients with mantle cell lymphoma who have difficulty tolerating ibrutinib. The study aims to see if acalabrutinib can help stop the growth of cancer cells by blocking specific enzymes that are necessary for cell growth.
Description
The main goal of this study is to see how well patients respond to acalabrutinib after three cycles of treatment. Researchers will also look at how many patients remain free of disease progression without experiencing severe side effects. They will monitor for any intolerable side effects that were previously noted with ibrutinib or new ones related to acalabrutinib. The study will also evaluate how long patients can live without the disease getting worse and how long the response to treatment lasts. Safety and side effects of acalabrutinib in patients who cannot tolerate ibrutinib will be assessed.
Additionally, researchers will collect blood and tissue samples to study changes in cancer cells and immune responses over time. This includes looking at genetic mutations, immune system markers, and minimal residual disease.
Patients will take acalabrutinib by mouth twice a day for 28-day cycles, continuing for up to 36 cycles unless the disease progresses or side effects become unacceptable. After finishing the treatment, patients will have follow-up visits every four months for two years, every six months for one year, and then annually for up to three years.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of mantle cell lymphoma with specific genetic markers.
- Need for treatment rather than observation.
- Previous treatment with ibrutinib stopped due to side effects, not disease progression.
- Intolerance to ibrutinib defined by specific side effects.
- Side effects from ibrutinib must have resolved to a mild level before starting acalabrutinib.
- Ability to understand and sign a consent form.
- Measurable disease by specific imaging criteria.
- Good overall health with a performance status of 2 or less.
- Adequate blood cell counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Men must agree to use barrier contraception if their partner is of childbearing potential.
- Patients with well-controlled HIV/AIDS are eligible.
Exclusion Criteria
- Previous treatment with acalabrutinib.
- Known genetic mutations that cause resistance to BTK inhibitors.
- Disease progression while on ibrutinib.
- Known severe allergic reactions to ibrutinib.
- Pregnant or breastfeeding women.
- Active hepatitis B infection.
- Central nervous system involvement with lymphoma.
- Active bleeding disorders or recent significant bleeding events.
- Uncontrolled autoimmune blood disorders.
- Ongoing side effects from previous ibrutinib treatment.
- Conditions affecting the absorption of acalabrutinib.
- Recent major surgery.
- Need for certain blood thinners or high-dose steroids.
- Serious heart conditions or uncontrolled blood pressure.
- Recent serious infections.
- Need for certain medications that interact with acalabrutinib.
- Other serious medical conditions that pose a risk to the patient.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.