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bone marrow procedure
adult t-cell leukemia/lymphoma
human chorionic gonadotropin
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
adult t-cell leukemia
anaplastic large cell lymphoma
large cell lymphoma
intestinal t-cell lymphoma
Some T-cell lymphomas and leukemias do not respond to standard treatment. Researchers hope to
develop a treatment that works better than current treatments.
To test if interleukin (IL-5) combined with avelumab is safe and effective for treating
People ages 18 and older with relapsed T-cell leukemias and lymphomas for which no standard
treatment exists or standard treatment has failed
Participants will be screened with:
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
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.
-Mature T-cell cancers are a phenotypically heterogeneous group of malignancies which
constitute 10-15% of all non-Hodgkin lymphomas (NHL). Patients with relapsed/refractory T
cell lymphomas have limited therapeutic options, making new therapeutic approaches extremely
-The immunologic effects of recombinant human Interleukin-15 (rhIL-15), a stimulatory
cytokine that promotes the differentiation and activation of NK cells, monocytes and longterm
CD8+ memory T-cells, has been assessed in several Phase 1 trials in cancer patients.
-Avelumab is an anti-programmed death ligand-1 (PD-L1) fully human IgG1 antibody that
inhibits PD1/PD-L1 interactions while leaving the PD1/PD-L2 pathway intact and enhances
immune activation against tumor cells. It has received U.S. FDA accelerated approval for the
treatment of patients with metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma.
-Unlike other approved anti-PD-L1/PD1 antibodies, avelumab induces lysis of tumor cells
via antibody-dependent cell-mediated cytotoxicity (ADCC), indicating an additional mechanism
of action. However, avelumab has not shown ADCC against normal immune cell subsets in humans.
-A significant number of T-cell malignancies express PD-L1, and since the anti-PD-L1 antibody
avelumab has shown ADCC activity in vitro, agents that may enhance ADCC by increasing number
and activity of Fc-binding effector cells such as rhIL15 could improve efficacy of avelumab
in these diseases.
-To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of
continuous intravenous infusion (civ) rhIL-15 administration in combination with standard
intravenous (IV) avelumab treatment
Age greater than or equal to 18 years of age
ECOG performance status of less than or equal to 1
Histologically or cytologically confirmed relapsed and/or refractory T-cell lymphoma
other than adult T-cell leukemia/lymphoma (ATLL), angioimmunoblastic T-cell lymphoma
(AITL), peripheral T-cell lymphoma T follicular helper phenotype (PTCLTFH), and
enteropathy-associated T-cell lymphoma (EATL).
Adequate organ and marrow function
Open-label, single-center, non-randomized Phase 1 study
Standard 3 + 3 design will be used to determine the MTD of dose-escalated rhIL-15 with
fixed dose avelumab with a small expansion cohort at the MTD
Maximum 6 cycles (28-day cycle) of combination therapy- To explore all dose levels,
including further evaluation in a dose expansion cohort, the
accrual ceiling will be set at 30 patients.
Clinical Study Identifier
National Cancer Institute (NCI)
Last Modified on
18 December 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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