If you have recently been diagnosed with diffuse large B-cell lymphoma (DLBCL), you may want to consider the ESCALADE study.
The ESCALADE study is a clinical research study designed to assess the effectiveness and safety of an investigational study drug in patients with diffuse large B-cell lymphoma (DLBCL). The investigational study drug is approved for patients with some other types of blood cancer, but is considered investigational in this study because it is not approved for patients with DLBCL like yours.
Acalabrutinib is a BTK inhibitor. This drug can stop cancer cells from repairing themselves, causing the cancer cells to die. It may also prevent new cancer cells from growing.
You may be eligible to participate in the study, if you:
There are other requirements that you will need to meet to join the study. A study doctor will go through these with you in more detail.
If you wish to participate in the study, you must first sign an Informed Consent Form, or ICF. The ICF explains the study and what you will need to do if you choose to take part. During the Informed Consent process, you should ask the study doctor and study team any questions, to ensure that you understand what will happen during the study.
You will then complete a screening process, during which the study team will carry out some assessments to see if you may begin the study treatment phase. During the screening process, if you met the enrolment criteria for the study, you will receive standard of care treatment, while you are being assessed to see if you meet the randomisation criteria and can continue in the study.
If you are able to continue with the study, you will be randomly assigned to receive one of the following:
You will have an equal chance (50/50) of being assigned either of these options.
The study treatment phase can last up to 6 months. You will need to visit the study clinic periodically, until you or the study doctor decide you should stop receiving the study treatment.
If your disease has not progressed after you have finished the treatment phase, you will enter the follow-up phase and:
If your disease has progressed after the treatment phase, instead of attending clinic visits you will be contacted by phone about every 6 months.
Future development is needed in treating DLBCL. More treatment options are needed, and they need to be more effective for more patients.
Clinical research studies are an essential part of developing new treatment options for people living with all sorts of diseases and conditions. These studies provide valuable information about safety and effectiveness before a new drug or treatment is approved.
Clinical studies follow standard and are closely regulated. Strict safety measures protect study patients, and a written plan called a protocol ensures that study procedure is conducted in accordance with all standards and regulations.