Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome
-
- STATUS
- Recruiting
-
- End date
- Sep 1, 2023
-
- participants needed
- 20
-
- sponsor
- National Cancer Institute (NCI)
Summary
- Background
Adult T-cell leukemia/lymphoma (ATLL) and mycosis fungoides/Sezary syndrome (MF/SS) are cancers that form in the T cells, a type of white blood cell that helps with the body s immune response. A combination of drugs might be able to better treat these cancers than existing therapies.
- Objective
To test if the drugs IL-15 and mogamulizumab are safe and effective to treat people with ATLL or MF/SS.
- Eligibility
People ages 18 and older with relapsed ATLL or MF/SS that has not responded to at least one standard treatment
- Design
Participants will be screened with:
Medical history
Physical exam
Blood (including HIV, hepatitis B and C), urine, lung, and heart tests
Bone marrow tests (if needed): A needle inserted in the participant s hip will take a small amount of marrow.
CT, PET and/or MRI scans
Tumor biopsy (if needed): A needle will take out a small piece of the participant s tumor.
Participants will get the study drugs by vein for up to six 28-day cycles. They will get IL-15 the first 5 days of each cycle. They will get mogamulizumab on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of the other cycles. They will be hospitalized for 1 week in cycle
- They may need to get a midline catheter. This is a soft tube put into a vein leading to the heart.
Participants will have repeats of the screening tests throughout the study.
After treatment, participants will have visits every 60 days for 6 months, every 90 days for 2 years, and then every 6 months for 2 years.
Description
- Background
-
- Advanced mycosis fungoides, its leukemic form Sezary syndrome (MF/SS), and adult T- cell leukemia/lymphoma (ATLL) are all aggressive mature T-cell malignancies which are considered incurable without an allogeneic stem cell transplant.
- Mogamulizumab is a defucosylated monoclonal antibody directed towards CCR4, a chemokine receptor expressed by the majority of MS/SS and ATLL cells. It is approved by the United States Food and Drug Administration for treatment of relapsed MF/SS, and is recommended by the National Comprehensive Cancer Network for treatment of ATLL.
- Defucosylation of mogamulizumab is thought to enhance its capacity for antibodydependent cell cytotoxicity (ADCC), which is mediated by natural killer (NK) cells and macrophages.
- The immunologic effects of recombinant human Interleukin-15 (rhIL-15), a stimulatory cytokine that promotes the differentiation and activation of NK cells, monocytes and long- term CD8+ memory T-cells, has been assessed in several phase I trials in cancer patients.
- Concomitant administration of rhIL-15 with mogamulizumab may further enhance the ADCC
capacity of the antibody and result in improved efficacy for patients with CCR4-
expressing cancers.
- Objectives
-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) mogamulizumab treatment
- Eligibility
-
- Age greater than or equal to 18 years of age
- ECOG performance status of less than or equal to 1
- Histologically or cytologically confirmed mycosis fungoides/S(SqrRoot)(Copyright)zary syndrome or adult T- cell leukemia/lymphoma relapsed after or refractory to at least one line of systemic treatment.
- Adequate organ and marrow function
- Design
-
- Open-label, single-center, non-randomized phase I study
- Standard "3 + 3" design will be used to determine the MTD of dose-escalated rhIL-15 with fixed dose of mogamulizumab, with an expansion cohort at the MTD
- Maximum 6 cycles (28-day cycles) of combination therapy
- To explore all dose levels, including further evaluation in a dose expansion cohort, and to account for unevaluable patients the accrual ceiling will be set at 20 patients.
Details
| Treatment | Mogamulizumab, rhIL-15 |
|---|---|
| Clinical Study Identifier | NCT04185220 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 17 January 2021 |
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