Overview

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies

Status:
Active, not recruiting

Trial end date:
2026-06-01

Target enrollment:

Participant gender:

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. - CT or PET scans and 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 IL-15 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. ...

Phase:

Phase 1

Details

Lead Sponsor:

National Cancer Institute (NCI)

Treatments:

Antibodies
Antibodies, Monoclonal
Avelumab