Active — Not RecruitingPhase 1

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

United States18 participantsStarted 2019-10-03

Plain-language 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. ...

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Diagnosis of hairy cell leukemia (HCL) or Hairy cell leukemia variant (HCLv). * Treatment required for either 1) Absolute neutrophil count (ANC) \<1/nL, 2) Hemoglobin \<10g/dL, 3) Platelets\<100/nL, 4) symptomatic splenomegaly, or 5) enlarging HCL mass \> 2cm in short axis. Patients who have eligible blood counts within 4 weeks from the initiation of study will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment. * Patients must be Pseudomonas-immunotoxin naive. * HCL or HCLv with at least 1 prior purine analog, and, for HCL patients with \>=2-years 1 month response, at least 1 other therapy. Age greater than or equal to 18 years as the disease under study, HCL/HCLv, has not been reported in children \< age 18. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to2 (Karnofsky greater than or equal to 60%) * Patients must have adequate organ and marrow function as defined below: * Total bilirubin less than or equal to 1.5 mg/dL, unless consistent with Gilbert's (ratio between total and direct bilirubin \> 5) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 ULN * Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min by Cockcroft-Gault equation, where creatinine clearance = …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recommended Safe Dose of Moxetumomab Pasudotox-tdfk

Timeframe: 4 weeks

Recommended Safe Dose of Rituximab/Ruxience

Timeframe: 4 weeks

Trial details

NCT IDNCT03805932

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-07-07

Results submitted2023-11-10

View on ClinicalTrials.gov More Hairy Cell Leukemia trials