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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

Primary Purpose

Hodgkin Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage II Adult Hodgkin Lymphoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lopinavir
ritonavir
polymerase chain reaction
flow cytometry
enzyme-linked immunosorbent assay
laboratory biomarker analysis
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring recurrent adult Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I

Arm II

Arm Description

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

Patients receive no therapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2010
Last Updated
November 28, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01165645
Brief Title
Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma
Official Title
Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no patients enrolled
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 14, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
No Intervention
Arm Description
Patients receive no therapy.
Intervention Type
Drug
Intervention Name(s)
lopinavir
Other Intervention Name(s)
ABT-378/r
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
ritonavir
Other Intervention Name(s)
Norvir, RIT
Intervention Description
Given orally
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Other Intervention Name(s)
PCR
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
enzyme-linked immunosorbent assay
Other Intervention Name(s)
ELISA
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Comparison of post-vaccination anti-rabies antibody titers between treatment groups
Time Frame
90 days
Title
Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups
Time Frame
90 days
Title
Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Rizza, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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