Study on Tafasitamab, Acalabrutinib, and Venetoclax for Treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07582159
This clinical trial is exploring a new combination of drugs—tafasitamab, acalabrutinib, and venetoclax—to see if they are safe and effective in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing a combination of three drugs to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Tafasitamab is a type of protein that helps the immune system target and kill cancer cells. Acalabrutinib blocks a protein that helps cancer cells grow, and venetoclax stops cancer cells from surviving. The trial aims to find out if this combination is safe and can effectively treat CLL/SLL.
Description
The main goals of this study are to check if the combination of tafasitamab, acalabrutinib, and venetoclax is safe and to see how well it works in treating CLL/SLL. The study will look at how many patients have a complete response, meaning no signs of cancer, and how long they stay cancer-free.
Participants will take acalabrutinib by mouth twice a day for the first two cycles, each lasting 28 days. In cycles 3 to 5, they will continue acalabrutinib and add venetoclax daily, along with tafasitamab given through an IV on specific days. In cycles 6 to 8, tafasitamab will be given less frequently, and in cycles 9 to 14, it will be given once per cycle.
Patients will have regular check-ups, including blood tests and scans, to monitor their health and the treatment's effects. After finishing the treatment, they will be followed up every 3 months, and then every 6 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of CLL/SLL.
- Must not have received prior treatment for CLL/SLL, except for steroids or rituximab for autoimmune issues.
- Must have active disease needing treatment based on specific symptoms or disease progression.
- Must be able to swallow pills.
- Must have certain blood counts and organ function levels within specified limits.
- Must agree to use effective birth control during and after the study if of childbearing potential.
- Must not have active infections like HIV, hepatitis B, or hepatitis C unless well-controlled.
- Must provide informed consent to participate.
Exclusion Criteria
- Cannot use high doses of corticosteroids regularly.
- Cannot have had major surgery recently.
- Cannot have uncontrolled bleeding disorders.
- Cannot have received certain medications or vaccines recently.
- Cannot have other active cancers, except for some treated skin or prostate cancers.
- Cannot have active infections or certain viral infections unless controlled.
- Cannot be pregnant or breastfeeding.
- Cannot have any condition that would make participating unsafe or difficult.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.