Title: Moxetumomab Pasudotox-tdfk (Lumoxiti ) and Rituximab (Rituxan ) for Relapsed Hairy Cell Leukemia
Recruiting
National Cancer Institute (NCI)
Phase 1
2019-10-03
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
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