Hodgkin LymphomaNCT01165645
Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma
A study testing lopinavir, ritonavir and polymerase chain reaction in people with Hodgkin Lymphoma and Stage I Adult Hodgkin Lymphoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage II Adult Hodgkin Lymphoma
- What is being tested?
- lopinavir, ritonavir and polymerase chain reaction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 14 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- lopinavir, ritonavir, polymerase chain reaction, flow cytometry, enzyme-linked immunosorbent assay
- Keywords
- recurrent adult Hodgkin lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavirDrug
Also called ABT-378/r
Given orally
ritonavirDrug
Also called Norvir, RIT
Given orally
polymerase chain reactionGenetic
Also called PCR
Correlative studies
flow cytometryOther
Correlative studies
enzyme-linked immunosorbent assayOther
Also called ELISA
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
Measured: 90 days
Secondary outcomes (3)
Comparison of post-vaccination anti-rabies antibody titers between treatment groups
Measured: 90 days
Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups
Measured: 90 days
Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completion14 Dec 2011
Why it stopped: no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Rizza, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165645
- Sponsor's protocol ID
- MC1083
- Other IDs
- NCI-2010-00880, MC1083, 08-006246, 21096
- Status last verified
- Oct 2015
- First submitted
- 14 Jul 2010
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness
- ClinicalTrials.gov ID
- NCT01165645
- Acronym / sponsor ID
- MC1083
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- 14 Dec 2011 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: lopinavir, Drug: ritonavir, Genetic: polymerase chain reaction, Other: flow cytometry, Other: enzyme-linked immunosorbent assay, Other: laboratory biomarker analysisPatients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm II | No intervention | –Patients receive no therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lopinavirAlso: ABT-378/rGiven orally | Drug | Arm I |
| ritonavirAlso: Norvir, RITGiven orally | Drug | Arm I |
| polymerase chain reactionAlso: PCRCorrelative studies | Genetic | Arm I |
| flow cytometryCorrelative studies | Other | Arm I |
| enzyme-linked immunosorbent assayAlso: ELISACorrelative studies | Other | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
Primary outcome
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
Time frame: 90 days
3 secondary outcomes
Comparison of post-vaccination anti-rabies antibody titers between treatment groups
Time frame: 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
Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Rizza, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lopinavir, ritonavir and polymerase chain reaction in people with Hodgkin Lymphoma and Stage I Adult Hodgkin Lymphoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.