Clinical Trials Using Moxetumomab Pasudotox
Clinical trials are research studies that involve people. The clinical trials on this list are studying Moxetumomab Pasudotox. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Title: Moxetumomab Pasudotox-tdfk (Lumoxiti ) and Rituximab (Rituxan ) for Relapsed Hairy Cell Leukemia
Background: Hairy cell leukemia (HCL) is a rare, slow-growing blood cancer in which the bone marrow makes too many of certain white blood cells. The antibody Rituximab binds to a protein in cancerous white blood cells and is often used to treat HCL. Researchers want to see if combining it with the drug Moxetumomab pasudotox-tdfk (also called Lumoxiti) can fight HCL better. Objective: To test the safety of Moxetumomab pasudotox taken with Rituximab for people with HCL or HCL variant. Eligibility: People age 18 years and older with HCL or HCL variant that has not responded to standard therapy Design: Participants will be screened with: Medical history Physical exam Blood, heart, and urine tests Test of blood oxygen levels Review of bone marrow. This can be from previous test results or a new sample. Scans Exercise test Participants will get the study drugs in up to 8 cycles. A cycle will last about 28 days. Both drugs will be given through a plastic tube in a vein. In the first week of cycle 1, participants will have: 1 visit to get Rituximab for 7.5 hours 3 visits to get Lumoxiti for 30 minutes per infusion In the first week of cycles 2-8, participants will have: 1. visit to get Rituximab for 2-4 hours and Lumoxiti for 30 minutes 2. visits to get Lumoxiti for 30 minutes per infusion Participants will be asked to drink lots of water and take aspirin during the cycles. They will get drugs to minimize allergic reactions. Participants will repeat screening tests at visits throughout the cycles and 1 follow-up visit. They may have an eye exam. Sponsoring Institute: National Cancer Institute ...
Location: National Institutes of Health Clinical Center, Bethesda, Maryland