Low-dose IL-2 for Treg Expansion and Tolerance (LITE) (LITE)
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ClinicalTrials.gov Identifier: NCT02949492 |
Recruitment Status :
Terminated
(Safety concerns)
First Posted : October 31, 2016
Last Update Posted : August 14, 2019
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Condition or disease | Intervention/treatment | Phase |
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Transplantation Liver Diseases | Drug: IL-2 (interleukin 2) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Low Dose IL-2 to Expand Endogenous Regulatory T-cells and Achieve Tolerance in Liver Transplantation |
Actual Study Start Date : | December 12, 2017 |
Actual Primary Completion Date : | January 31, 2019 |
Actual Study Completion Date : | January 31, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: IL-2 arm
Liver recipients <50 years old and 2-6 years after transplantation will receive IL-2 and gradually discontinue their immunosuppressive medication
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Drug: IL-2 (interleukin 2)
Low-dose IL-2 will be initiated while study participants remain on a calcineurin inhibitor immunosuppressant. Following 4 weeks of treatment, participants showing at least a 2-fold increase in peripheral blood absolute Treg numbers, stable liver function and no adverse effects will undergo a liver biopsy to exclude sub-clinical graft damage, and subsequently will initiate immunosuppression withdrawal. Low-dose IL-2 will be maintained for a total of 6 months.
Other Name: Proleukin |
- Discontinuation of immunosuppression drugs [ Time Frame: 12 months post IS withdrawal ]The primary objective is to determine the capacity of a short course of low-dose IL-2 to facilitate the complete discontinuation of immunosuppressive drugs in liver recipients 2-6 years after transplantation.
- Proportion of tolerant participants remaining free of rejection [ Time Frame: 12 months post IS withdrawal ]Measures of rejection in patients (incidence, severity, timing, steroid resistant rejection, chronic rejection) and to investigate if liver transplant recipients under IS become operationally tolerant over time.
- Development of serum anti-HLA antibodies [ Time Frame: 12 months post IS withdrawal ]To determine if the presence of donor-specific anti-HLA antibodies influence the success of IS withdrawal, and whether IS withdrawal promotes the development of anti-HLA antibodies in liver transplant recipients.
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult liver transplant recipients 2-6 years post-transplant and age <50 years;
- Recipient of single organ transplant only;
- Liver function tests: direct bilirubin and ALT <2 x ULN at the screening visit;
- On calcineurin inhibitor (CNI) based IS; with or without one of the following: Low dose mycophenolic acid (≤ 1080 mg daily), mycophenolate mofetil (MMF ≤ 1500 mg daily), or azathioprine (≤ 150 mg daily);
- Provision of written informed consent.
Exclusion Criteria:
1.1. Serum positivity for HCV-RNA at screening; 2. Serum positivity for HIV-1 infection, HBV surface antigen or HBV-DNA at screening; 3. Active liver or systemic immune-mediated disease in which IS discontinuation is inadvisable (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis); 4. Acute or chronic rejection within the 52 weeks prior to screening; 5. GFR <40 mL/min (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI be required); 6. The need for chronic anti-coagulation that cannot be safely discontinued to safely perform for a liver biopsy; 7. Screening liver biopsy showing signs of clinically significant histological damage will preclude continuation in the trial; 8. Maintenance immunosuppressive therapy with a mTOR inhibitor (sirolimus or everolimus); 9. Active infection or malignancy; 10. Inability to comply with study directed treatment; 11. Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial (including severe cardiac disease, severe respiratory disease with O2 blood saturation <92%, any other major organ dysfunction, and Eastern Cooperative Oncology Group (ECOG) performance status of ECOG > 1).
12. Participation in another IMP study within 3 months from consent; 13. Any known allergy or intolerance to the IMP components; 14. Pregnancy or lactation; 15. Lack of effective methods of contraception for women and men of childbearing potential; 16. Hypersensitivity to Proleukin or to any of the excipients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949492
United Kingdom | |
Alberto Sanchez-Fueyo | |
London, United Kingdom, SE5 9RS |
Principal Investigator: | Alberto Sanchez-Fueyo | King's College London |
Responsible Party: | King's College London |
ClinicalTrials.gov Identifier: | NCT02949492 |
Other Study ID Numbers: |
LITE-01 |
First Posted: | October 31, 2016 Key Record Dates |
Last Update Posted: | August 14, 2019 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Liver Transplant Immunosuppression |
Liver Diseases Digestive System Diseases Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |