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ACTIVE NOT RECRUITING
NCT03805932
PHASE1

Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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. ...

Official title: A Phase I Study of Moxetumomab Pasudotox-tdfk (Lumoxiti (TM)) and Either Rituximab (Rituxan (R)) or Ruxience for Relapsed Hairy Cell Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2019-10-03

Completion Date

2026-06-30

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

Moxetumomab Pasudotox-tdfk

Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle.

BIOLOGICAL

Rituximab

Rituximab will be administered at 375mg/m\^2 intravenous (iv), 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.

BIOLOGICAL

Ruxience

Ruxience will be administered at 375mg/m\^2 intravenous (iv), 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)

DRUG

Dexamethasone

12 mg Cycle 1, Day -2; Cycles 2-8, Day 1. Administer 0.5-2 hours before rituximab/Ruxience. If participant has previous reaction to rituximab/Ruxience, give 12mg. If participants tolerate rituximab/Ruxience without problems, may hold at discretion of provider. Pre-medications are given prior to rituximab/Ruxience on day 1.

DRUG

Acetaminophen

650 mg Cycle 1, Day -2, Day 1, Day 3, Day 5. To be given 30-90 minutes prior to every moxetumomab pasudotox-tdfk infusion and recommended every 6 hours x 4 after the end of infusion; Cycles 2-8, Day 1, Day 3, Day 5. To be given 30-90 minutes prior to every moxetumomab pasudotox-tdfk infusion and recommended every 6 hours x 4 after the end of infusion. Pre-medications are given prior to rituximab/Ruxience on day 1.

DRUG

Diphenhydramine

25-50 mg Cycle 1, Day -2; Cycles 2-8, Day 1. Pre-medications are given prior to rituximab/Ruxience on day 1. May be given prior to moxetumomab pasudotox-tdfk at discretion of principal investigator.

DRUG

Famotidine

20-40 mg Cycle 1, Day -2; Day 1, Day 3, Day 5. To be given 30-90 minutes prior to every moxetumomab pasudotox-tdfk infusion and is recommended every 12 hours x 2 after the end of infusion; Cycles 2-8, Day 1, Day 3, Day 5. To be given 30-90 minutes prior to every moxetumomab pasudotox-tdfk infusion and is recommended every 12 hours x 2 after the end of infusion. Pre-medications are given prior to rituximab/Ruxience on day 1.

DRUG

Aspirin

81 mg Cycle 1, Days 1-8; Cycles 2-8, Days 1-8. Only if platelet counts ≥ 100 x 109/L.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States