Ongoing Clinical Trials for Prolymphocytic Leukaemia
There is currently 1 ongoing clinical trial for Prolymphocytic Leukaemia. This trial is investigating the use of acalabrutinib, a targeted therapy, for patients whose disease has relapsed or not responded to previous treatments. The study is being conducted in Italy and aims to determine the safest and most effective dosage of this medication.
Clinical trial locations
Study on the Effects of Acalabrutinib in Patients with Chronic Lymphocytic Leukemia, Richter’s Syndrome, or Prolymphocytic Leukemia
This clinical trial is investigating acalabrutinib, a medication that works by blocking a specific protein involved in the growth and survival of cancer cells. The study is designed for patients with several related blood cancers, including Prolymphocytic Leukaemia, which is a rare and aggressive form of the disease that progresses more quickly than other types.
Main inclusion criteria:
- Adults aged 18 years or older with a confirmed diagnosis of Prolymphocytic Leukaemia
- The condition must have transformed from another type of blood cancer and be confirmed by biopsy
- Patients must have measurable disease, defined as at least one lymph node measuring 2 cm or larger
- Must have active disease requiring treatment, which may include symptoms such as enlarged spleen or lymph nodes, increasing white blood cell counts, or unexplained weight loss, fevers, or night sweats
- Ability to care for themselves and carry out daily activities, though unable to work
- Willingness to use effective birth control during the study
- Ability to swallow tablets or capsules and participate in all study procedures
Main exclusion criteria:
The trial documentation contains some conflicting information regarding exclusion criteria. It states that patients with Prolymphocytic Leukaemia cannot participate, while simultaneously including them in the inclusion criteria. This inconsistency should be clarified with the trial team before considering participation.
Focus and goals:
The main purpose of this study is to determine the safety and appropriate dosage of acalabrutinib for patients with these conditions. The trial uses a dose escalation approach, meaning participants will receive increasing amounts of the medication to identify the most effective and safe level. Researchers will closely monitor how patients’ bodies process the medication and how it affects the disease. The study includes regular check-ups and tests, including blood work and other evaluations, to measure treatment response and ensure patient safety. The trial is expected to continue until June 2027.
Investigational drug:
The medication being tested is acalabrutinib, which is available as Calquence 100 mg film-coated tablets or hard capsules. It is taken orally and belongs to a class of drugs called kinase inhibitors. Acalabrutinib works by inhibiting Bruton’s tyrosine kinase, a protein that plays a crucial role in the growth and survival of cancer cells. This targeted approach aims to stop cancer cells from multiplying while potentially causing fewer side effects than traditional chemotherapy.
Summary
Currently, only one clinical trial is actively recruiting patients with Prolymphocytic Leukaemia. This trial is being conducted in Italy and focuses on acalabrutinib, a newer targeted therapy that represents an important advancement in treating this rare and aggressive form of leukaemia. The study is particularly significant because it includes patients whose disease has not responded to previous treatments, addressing an important unmet medical need.
The trial uses a careful dose-escalation approach to identify the optimal balance between effectiveness and safety. Patients considering participation should note the discrepancy in the trial documentation regarding exclusion criteria and discuss this with the research team to clarify eligibility. Given that this is currently the only active trial for this condition, it may represent an important treatment option for eligible patients who have exhausted other alternatives.
