Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
Status:
Active, not recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Background:
Chronic lymphocytic leukemia (CLL) is a blood cancer. Recombinant human interleukin 15
(IL-15) is a manmade protein. Obinutuzumab is a protein made to deactivate cancer cells.
Researchers want to see if treating people with CLL with both proteins improves their
outcomes.
Objectives:
To find the safe dose of IL-15 with obinutuzumab. To identify its effects, including on the
immune system and cancer.
Eligibility:
Adults at least 18 years old who have certain CLL that standard therapy has failed
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Evaluation of ability to do daily activities
- Blood, heart, and urine tests
Participants may also be screened with:
- A small amount of bone marrow removed by needle in the hipbone
- Scans of the body and/or brain
The study will be done in 28-day cycles for up to 6 cycles.
Participants will get the study drugs through a catheter and pump.
Cycle 1: Participants will stay in the clinic for week 1. They will get:
- IL-15 as a continuous intravenous infusion over 24 hours on days 1-5
- Obinutuzumab as an infusion on 4 days, over about 4 hours. The doses for this will
increase.
Other cycles: Participants will come to the clinic days 1 5 and get IL-15 as in cycle 1. They
will get obinutuzumab on day 4.
During the study, participants:
- Will repeat screening tests
- Will get standard medicines for side effects
- May give blood, saliva, and tumor samples for research
After treatment, participants will have follow-up visits every 3 months for 1 year, then
every 6 months for up to 5 years. After that, participants may be called or emailed.
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