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

NCT01165645 | Withdrawn DMC

• 4 other identifiers: MC1083NCI-2010-0088008-00624621096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Lymphoma; Stage I Adult Hodgkin Lymphoma; Stage II Adult Hodgkin Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage IV Adult Hodgkin Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups

  90 days

Secondary Outcomes (3)

• Comparison of post-vaccination anti-rabies antibody titers between treatment groups

  90 days

• Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups

  90 days

• Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups

  90 days

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lopinavir; Drug: ritonavir; Genetic: polymerase chain reaction; Other: flow cytometry; Other: enzyme-linked immunosorbent assay; Other: laboratory biomarker analysis

Arm II

NO INTERVENTION

Patients receive no therapy.

Interventions

lopinavir DRUG

Given orally

Also known as: ABT-378/r

Arm I

ritonavir DRUG

Given orally

Also known as: Norvir, RIT

Arm I

polymerase chain reaction GENETIC

Correlative studies

Also known as: PCR

Arm I

flow cytometry OTHER

Correlative studies

Arm I

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Lopinavir; Ritonavir; Polymerase Chain Reaction; Flow Cytometry; Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Stacey Rizza, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 20, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: December 14, 2011
• Last Updated: December 1, 2022

Record last verified: 2015-10

Locations

US (1)