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NCT02689453 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02689453: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02689453 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02689453, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Background: Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better treatment for ATL. Objectives: To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL. Also, to determine the safe dose of this combination and identify side effects and effects on the immune system. Eligibility: Adults 18 years and older with chronic or acute ATL who have not been helped by other treatments. Design: Participants will be screened with tests that are mostly part of their usual cancer care. They will sign a separate consent form for this. Weeks 1 and 2: Participants will have a total of 10 visits. They will: * Get rhIL-15 under the skin by needle. * Have a physical exam and vital signs measured. * Give blood samples. * Answer questions about their health and their medicines. Week 3: Participants will stay in the clinic. They will: * Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5. * Take medicines to decrease side effects. * Have a computed tomography (CT) scan to evaluate the treatment. * Have a physical exam and vital signs measured. * Give blood samples. Answer questions about their health and medicines. Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have outpatient visits these weeks. After treatment, participants will have follow-up visits every few months for up to 2 years. At these visits, participants will give blood samples and have CT scans.
Interventions
- BIOLOGICAL alemtuzumab
- BIOLOGICAL IL-15 plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02689453
The ClinicalTrials.gov registry entry for NCT02689453 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which alemtuzumab is the first listed.
NCT02689453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02689453 about?
NCT02689453 is a clinical study titled "Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)". Background: Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better treatment for ATL. Objectives: To test if giving rhIL-15 combined with alemtuzumab improves the outcome ...
What is the current status of trial NCT02689453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-01-19. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT02689453?
The interventions under investigation include: alemtuzumab (BIOLOGICAL), IL-15 plus (BIOLOGICAL).
Who is sponsoring clinical trial NCT02689453?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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