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Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)

NCT02689453 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-04-29

Study results available
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Summary

Background:

Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better treatment for ATL.

Objectives:

To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL. Also, to determine the safe dose of this combination and identify side effects and effects on the immune system.

Eligibility:

Adults 18 years and older with chronic or acute ATL who have not been helped by other treatments.

Design:

Participants will be screened with tests that are mostly part of their usual cancer care. They will sign a separate consent form for this.

Weeks 1 and 2: Participants will have a total of 10 visits. They will:

* Get rhIL-15 under the skin by needle.
* Have a physical exam and vital signs measured.
* Give blood samples.
* Answer questions about their health and their medicines.

Week 3: Participants will stay in the clinic. They will:

* Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5.
* Take medicines to decrease side effects.
* Have a computed tomography (CT) scan to evaluate the treatment.
* Have a physical exam and vital signs measured.
* Give blood samples.

Answer questions about their health and medicines.

Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have outpatient visits these weeks.

After treatment, participants will have follow-up visits every few months for up to 2 years. At these visits, participants will give blood samples and have CT scans.

Conditions

  • T-Cell Lymphoma Relapsed
  • Adult T-Cell Leukemia (ATL)
  • Peripheral T-Cell Lymphoma (PTCL)
  • Cutaneous T Cell Lymphoma (CTCL)
  • T-Cell Prolymphocytic Leukemia

Interventions

BIOLOGICAL

IL-15 plus

Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.

BIOLOGICAL

alemtuzumab

Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kevin Conlon, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2021-06-15
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689453 on ClinicalTrials.gov