Moxetumomab + Rituximab/Ruxience for Hairy Cell Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Robert J Kreitman, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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/Ruxience 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/Ruxience 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. The study 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 or Ruxience 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/Ruxience 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. ...

Eligibility Criteria

Adults over 18 with Hairy Cell Leukemia (HCL) or its variant, who haven't responded to standard therapy. They must have certain blood count levels, be Pseudomonas-immunotoxin naive, and have adequate organ function. Participants should not be pregnant or breastfeeding and must use effective contraception. Those with a history of certain medical conditions like heart disease are excluded.

Inclusion Criteria

Total bilirubin less than or equal to 1.5 mg/dL, unless consistent with Gilbert s (ratio between total and direct bilirubin > 5)

Patients must be Pseudomonas-immunotoxin naive.

I am 18 years old or older.

Exclusion Criteria

I have Hepatitis B but am under treatment and my viral load is low.

Patients with corrected QT interval (Frederica) elevation > 500 msec (manually over-read by medically qualified person) based on at least two separate 12-lead ECGs.

I have a history of blood clots and a genetic condition that makes my blood clot more easily.

Treatment Details

Interventions

• Moxetumomab Pasudotox-tdfk (Immunotoxin)
• Rituximab (Monoclonal Antibodies)
• Ruxience (Monoclonal Antibodies)

Trial Overview The trial is testing the safety of combining Moxetumomab pasudotox-tdfk (Lumoxiti) with Rituximab/Ruxience in patients with relapsed HCL. The treatment involves up to eight cycles of these drugs administered intravenously, along with medications to prevent allergic reactions and instructions for hydration and aspirin intake.

Participant Groups

Group I: Moxetumomab - Dose Expansion 40 mcg/kg Experimental Treatment 7 Interventions

Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience

Group II: Moxetumomab - Dose Escalation 30 mcg/kg Experimental Treatment 7 Interventions

Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References