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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). 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.
Primary Outcome
MTD is defined as the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and the dose below that at which at least 2 (of≤6) participants have DLT as a result of the drug. A DLT is defined as any grade 3 or 4 toxicity possibly, probably or definitely related to the rhIL-15 treatment that occurs during the first 6 weeks of treatment with some exceptions such as grade 3 or 4 lymphopenia, and grade 3 neutropenia
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 |
What the finished NCT02689453 record still lists
NCT02689453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which alemtuzumab is the first listed.
NCT02689453 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02689453's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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