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

NCT ID: NCT01165645

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-14

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

lopinavir

Intervention Type: DRUG

Given orally

ritonavir

Intervention Type: DRUG

Given orally

polymerase chain reaction

Intervention Type: GENETIC

Correlative studies

flow cytometry

Intervention Type: OTHER

Correlative studies

enzyme-linked immunosorbent assay

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm II

Patients receive no therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

lopinavir

Given orally

Intervention Type: DRUG

ritonavir

Given orally

Intervention Type: DRUG

polymerase chain reaction

Correlative studies

Intervention Type: GENETIC

flow cytometry

Correlative studies

Intervention Type: OTHER

enzyme-linked immunosorbent assay

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

ABT-378/r; Norvir; RIT; PCR; ELISA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey Rizza, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2010-00880

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC1083

Identifier Type: OTHER

Identifier Source: secondary_id

08-006246

Identifier Type: OTHER

Identifier Source: secondary_id

21096

Identifier Type: OTHER

Identifier Source: secondary_id

MC1083

Identifier Type: -

Identifier Source: org_study_id