Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma

November 28, 2022 updated by: Mayo Clinic

Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness

RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic effect may boost the immune system to help the body create a better immune response to vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir together in improving immune response to vaccines in patients with complete remission following a bone marrow transplant for Hodgkin lymphoma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES: I. Compare TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups. SECONDARY OBJECTIVES: I. Compare post-vaccination anti-rabies antibody titers between treatment groups. II. Compare post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups. III. Compare post-vaccination anti-rabies ELISPOT reaction between treatment groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral lopinavir and oral ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive no therapy. All patients then receive a neo-antigen rabies vaccine.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects who are in complete remission at Day +100 after a bone marrow transplant for Hodgkins Lymphoma
  • Normal AST or ALT, serum creatinine and 12-lead electrocardiogram within the previous 6 months
  • Females of childbearing potential must have negative beta-HCG (urine or plasma) within the last month and agree to effective contraception during the course of the study
  • Willingness and ability to give informed consent
  • Willingness and ability to take pills twice a day for 28 days

Exclusion Criteria:

  • Known HIV positive
  • Screening ALT or AST greater than 3X upper limit of normal
  • Baseline QTc greater than 500 msec
  • Current treatment with immunosuppressive agent (systemic glucocorticoid, cyclosporine, mycophenolate, azathioprine, sirolimus, Rituximab, infliximab, adalimumab)
  • Current treatment with any of the following: cisapride, ergot derivatives, amiodarone, quinidine, terfenadine, astemizole, rifampin/rifabutin, carbamazepine, phenobarbital, sildenafil, St. John's wort, azithromycin, carbamazepine, HIV anti-virals, methadone, pimozide, phenytoin, sedative hypnotics (midazolam, triazolam), HMG-CoA reductase inhibitors (lovastatin, simvastatin, atorvastatin)
  • Active malignancy requiring chemotherapy or radiation
  • Baseline creatinine of > 2.0
  • Active infection requiring systemic anti-infective agent (excluding prophylactic antibiotics)
  • Hypersensitivity to processed bovine gelatin, chicken protein, neomycin, amphotericin B or chlortetracycline
  • Subject must not be on medications that interact with the metabolism of protease inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Other: flow cytometry
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
  • PCR
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Names:
  • ELISA
Drug: lopinavir
Given orally
Other Names:
  • ABT-378/r
Drug: ritonavir
Given orally
Other Names:
  • Norvir
  • RIT
NO_INTERVENTION: Arm II
Patients receive no therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of post-vaccination anti-rabies antibody titers between treatment groups
Time Frame: 90 days
90 days
Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups
Time Frame: 90 days
90 days
Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Study Chair: Stacey Rizza, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

December 14, 2011

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (ESTIMATE)

July 20, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC1083 (OTHER: Mayo Clinic Cancer Center)
  • NCI-2010-00880 (REGISTRY: NCI's CTRO)
  • 08-006246 (OTHER: Mayo Clinic IRB)
  • 21096 (OTHER: Abbott Lab Protocol)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hodgkin Lymphoma

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe