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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01165645
First received: July 14, 2010
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Hodgkin Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage IV Adult Hodgkin Lymphoma
 Drug: lopinavir
Drug: ritonavir
Genetic: polymerase chain reaction
Other: flow cytometry
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of post-vaccination anti-rabies antibody titers between treatment groups [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.
 Drug: lopinavir
Given orally
Other Name: ABT-378/r
Drug: ritonavir
Given orally
Other Names:
  • Norvir
  • RIT
Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR
Other: flow cytometry
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Other: laboratory biomarker analysis
Correlative studies
No Intervention: Arm II
Patients receive no therapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165645

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Stacey Rizza, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Stacey A Rizza, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01165645     History of Changes
Other Study ID Numbers: MC1083, NCI-2010-00880, MC1083, 08-006246, 21096
Study First Received: July 14, 2010
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ritonavir
Lopinavir
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013