Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Dana-Farber Cancer Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Lakshmi Nayak, MD|
|Principal Investigator Affiliation||Dana-Farber Cancer Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Central Nervous System Lymphoma, Refractory Central Nervous System Lymphoma, Recurrent Central Nervous System Lymphoma|
This is an open-label, dose-escalation phase 1/2 study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Acalabrutinib in patients with recurrent or refractory CNS lymphoma (R/R CNSL). Acalabrutinib has been studied in lab experiments and in other types of cancer, and information from these studies suggests that acalabrutinib may be beneficial for people with recurrent or refractory central nervous system lymphoma (CNSL). Acalabrutinib targets a vulnerable part of cancer cells which leads to an inhibition of the growth of cancer cells. The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for recurrent or refractory central nervous system lymphoma (CNSL) but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse. Approximately 15 to 21 participants will be enrolled in phase1 and approximately 28 patients will be enrolled Phase 2. AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, acalabrutinib.
Experimental: Acalabrutinib Dose Escalation
Phase 1 Dose escalation will occur using a 3+3 dose escalation approach, evaluating three separate dose levels. Acalabrutinib 200mg 2x daily Acalabrutinib 300mg 2x daily Acalabrutinib 400mg 2x daily
Experimental: Acalabrutinib Dose Expansion
Phase 2 Participants will receive Acalabrutinib at the pre-determined dosage established in Phase 1.
Drug: - Acalabrutinib
Tablet taken by mouth twice daily
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.