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NCT03805932 · ClinicalTrials.gov registry record · Phase 1
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
A Phase 1 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03805932: Active Phase 1 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
NCT03805932 is a Phase 1 study of Hairy Cell Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03805932, a Phase 1 study of Hairy Cell Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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. ...
Primary Outcome
Recommended safe dose of moxetumomab pasudotox-tdfk is defined as the treatment of 10 participants with no more than 2 experiencing a dose-limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threa
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Dexamethasone
- BIOLOGICAL Rituximab
- DRUG Moxetumomab Pasudotox-tdfk
- BIOLOGICAL Ruxience
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03805932 still lists
NCT03805932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Acetaminophen is the first listed.
NCT03805932 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03805932 about?
NCT03805932 is a clinical study titled "Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience 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/Ruxience binds to a protein in cancerous white blood cells and is often used to treat HCL. Researchers want to see if combining it ...
What is the current status of trial NCT03805932?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-10-03. Estimated completion is 2026-06-30.
What conditions does trial NCT03805932 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT03805932?
The interventions under investigation include: Acetaminophen (DRUG), Dexamethasone (DRUG), Rituximab (BIOLOGICAL), Moxetumomab Pasudotox-tdfk (DRUG), Ruxience (BIOLOGICAL).
Who is sponsoring clinical trial NCT03805932?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03805932 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03805932's enrollment target sits among peer trials
18 16th of 15 the lowest of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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