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NCT03905135 · ClinicalTrials.gov registry record · Phase 1
Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03905135: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03905135 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03905135, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: Some T-cell lymphomas and leukemias do not respond to standard treatment. Researchers hope to develop a treatment that works better than current treatments. Objective: To test if interleukin (IL-5) combined with avelumab is safe and effective for treating certain cancers. Eligibility: People ages 18 and older with relapsed T-cell leukemias and lymphomas for which no standard treatment exists or standard treatment has failed Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, heart, and lung tests * Possible tumor biopsy * Bone marrow biopsy: A small needle will be inserted into the hipbone to take out a small amount of marrow. * Computed tomography (CT) or positron emission tomography (PET) scans and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body. Participants will get the study drugs for 6 cycles of 28 days each. They will have a midline catheter inserted: A tube will be inserted into a vein in the upper chest. They will get Interleukin-15 (IL-5) as a constant infusion over the first 5 days of every cycle. They will get avelumab on days 8 and 22 of each cycle. They will be hospitalized for the first week of the first cycle. Participants will have tests throughout the study: * Blood and urine tests * Another tumor biopsy if their disease gets worse * Scans every 8 weeks * Possible repeat MRI * Another bone marrow biopsy at the end of treatment, if there was lymphoma in the bone marrow before treatment, and they responded to treatment everywhere else. After they finish treatment, participants will have visits every 60 days for the first 6 months. Then visits will be every 90 days for 2 years, and then every 6 months for 2 years. Visits will include blood tests and may include scans.
Interventions
- BIOLOGICAL Avelumab
- DRUG rhIL-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-06-07 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03905135
The ClinicalTrials.gov registry entry for NCT03905135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 Avelumab is the first listed.
NCT03905135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03905135 about?
NCT03905135 is a clinical study titled "Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies". Background: Some T-cell lymphomas and leukemias do not respond to standard treatment. Researchers hope to develop a treatment that works better than current treatments. Objective: To test if interleukin (IL-5) combined with avelumab is safe and effective for treating certain cancers. Eligibility...
What is the current status of trial NCT03905135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-06-07. Estimated completion is 2022-05-17.
What interventions are being tested in trial NCT03905135?
The interventions under investigation include: Avelumab (BIOLOGICAL), rhIL-15 (DRUG).
Who is sponsoring clinical trial NCT03905135?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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