Chronic Lymphocytic LeukemiaPhase 1/2NCT00962715
Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia
A Phase 1/2 study testing Influenza Vaccine Trivalent Inactivated (TIV), Pegylated interferon (PEGrIFN-α, Pegasys) and Interferon (IFNα, Roferon-A) in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Influenza Vaccine Trivalent Inactivated (TIV), Pegylated interferon (PEGrIFN-α, Pegasys) and Interferon (IFNα, Roferon-A)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to not given
- Phase
- Phase 1/2
- 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
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Patients with histologically or cytologically confirmed diagnosis of chronic lymphocytic leukemia according to established guidelines.
- Patients with Rai stages 0 to 4.
- Age >/= 18 years old.
- If patients have been treated with antineoplastic therapy, it must have been finished 3 months or longer prior to enrollment.
- Patients with complete or partial remission and those with stable (CLL) disease will be considered.
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- Patients who have received influenza vaccine in past 4 months will also be considered.
- Patients willing to receive recombinant cytokine.
- Patient willing to receive commercially available influenza vaccine that will not provide protection against the following years of influenza strains.
- Patients must have adequate hepatic function defined as follows: total bilirubin </= 2.0 mg/dL; SGOT and /or SGPT </= 3 x upper normal limit of the reference laboratory value unless liver function abnormalities are considered due to underlying cancer or congenital hemolytic disorders.
- Patient should avoid H2 blockers while on study. However, if H2 blockers are required to use, this will be reported and will be taken in consideration during response rate analysis.
- Females patients who are able to have children must agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control during the time period starting 2 weeks prior to enrollment through 1 month from last vaccination dose. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge and condom. If they suspect pregnancy during the study, they must notify the study doctor.
Who cannot join
- Concurrent serious medical illness in the opinion of Principle Investigator that could potentially interfere with protocol compliance.
- Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival is 5 years).
- History of known chronic viral infections within 12 months, including HIV and Hepatitis B or Hepatitis C. A screening for hepatitis or HIV will not be performed for this study.
- Positive screening pregnancy test within 2 weeks in non-menopausal women or breast-feeding.
- Patients with known allergy to either vaccine or interferon preparation.
- Patients with neutropenia (ANC < 500 cells/uL) within 4 weeks.
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- Patients with lymphocytopenia (ALC < 300 cells/uL) within 4 weeks.
- Concomitant use of investigational vaccines and/or medications within four weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
- Receipt of immunoglobulin in 3 months.
- Subject is enrolled in a conflicting clinical trial.
- History of Guillain-Barre Syndrome.
- Has an acute illness including an oral temperature greater than 100.4°F, within one week of vaccination.
- In patients who have prior therapy with fludarabine or alemtuzumab (Campath®), the treatment must have completed 12 months prior to enrollment.
- In patients who have prior therapy with Rituximab (Rituxan®), the treatment must have completed 6 months prior to enrollment.
- Patients with history of medically significant psychiatric disease, especially endogenous depression (not reactive to diagnosis of cancer), psychosis and bipolar disorder.
- Patients with seizure disorders requiring anticonvulsant therapy.
- Patients with history of severe cardiac disease with New York Heart Association (NYHA) grade 3 or 4.
- Patients with severe renal disease requiring hemodialysis.
- Patients who have received H2 blockers such as Ranitidine, Cimetidine, or Famotidine within 4 weeks prior to enrollment.
About this study
Official title: A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia
The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).
Read the detailed description
The Study Drugs:
Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.
TIV is designed to prevent the flu.
Screening Test:
Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need to be drawn. Women who are able to have children must have a negative blood (about 1 teaspoon) blood test within 2 weeks of study entry.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups.
If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2, you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will receive interferon with TIV.
You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the study doctor, study staff, and you will know which group you are in.
Study Drug Administration:
You will receive TIV through a needle into a muscle in your arm (the arm you do not write with) on Days 1 and 28.
- If you are in Group 1, you will only receive TIV
- If you are in Group 2, you will receive pegylated interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
- If you are in Group 3, you will receive interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
After you are given the injection(s), you will be watched for 15 minutes in the clinic before you are allowed to go home.
You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any symptoms you may be experiencing, and you will also record your body temperature.
Study Visits:
On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to the flu virus.
On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will be reviewed. If you cannot come to the clinic, a member of the research staff will call you to review this information. This phone call will take 15-30 minutes.
On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to the flu virus.
On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit, you may have your blood drawn at a local clinic. You will then mail the blood to the study doctor in a pre-paid envelope.
On Month 6, you will be called and asked about any side effects you may have experienced. This phone call will take 15-30 minutes.
Length of Study:
You will be considered off study after the Month 6 phone call. You will be taken off-study early if intolerable side effects or an allergic reaction occurs.
This is an investigational study. TIV, pegylated interferon, and interferon are FDA approved and commercially available. At this time, the use of pegylated interferon and standard interferon with TIV is only being used for research.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Influenza Vaccine Trivalent Inactivated (TIV), Pegylated interferon (PEGrIFN-α, Pegasys), Interferon (IFNα, Roferon-A)
- Keywords
- Leukemia, CLL, Influenza Vaccine Trivalent Inactivated, TIV, Flu, Pegasys, Pegylated interferon, Roferon, Interferon
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine Trivalent Inactivated (TIV)Biological
15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.
Pegylated interferon (PEGrIFN-α, Pegasys)Drug
Also called Pegasys, Peginterferon alfa-2a
180 μg (0.5 ml) before receiving TIV, through a needle under the skin.
Interferon (IFNα, Roferon-A)Drug
Also called Roferon-A, Interferon alfa-2a
3 million units (0.5 ml) before receiving TIV, through a needle under the skin.
| Study group | Role | What they receive |
|---|---|---|
| TIV | Experimental | TIV (Influenza Vaccine Trivalent Inactivated) alone Receives: Biological: Influenza Vaccine Trivalent Inactivated (TIV) |
| TIV + PEGrIFN-α | Experimental | TIV + Pegylated Interferon Receives: Biological: Influenza Vaccine Trivalent Inactivated (TIV); Drug: Pegylated interferon (PEGrIFN-α, Pegasys) |
| TIV + IFNα | Experimental | TIV + Interferon Receives: Biological: Influenza Vaccine Trivalent Inactivated (TIV); Drug: Interferon (IFNα, Roferon-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity rate
Measured: Day 1, 8, 28, 56 and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Safdar, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962715
- Sponsor's protocol ID
- 2007-0145
- Status last verified
- Aug 2012
- First submitted
- 19 Aug 2009
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00962715
- Acronym / sponsor ID
- 2007-0145
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, CLL, Influenza Vaccine Trivalent Inactivated, TIV, Flu, Pegasys, Pegylated interferon, Roferon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2011
- First posted
- 20 Aug 2009 (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.
The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).
Detailed description
The Study Drugs:
Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.
TIV is designed to prevent the flu.
Screening Test:
Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need to be drawn. Women who are able to have children must have a negative blood (about 1 teaspoon) blood test within 2 weeks of study entry.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups.
If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2, you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will receive interferon with TIV.
You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the study doctor, study staff, and you will know which group you are in.
Study Drug Administration:
You will receive TIV through a needle into a muscle in your arm (the arm you do not write with) on Days 1 and 28.
- If you are in Group 1, you will only receive TIV
- If you are in Group 2, you will receive pegylated interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
- If you are in Group 3, you will receive interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
After you are given the injection(s), you will be watched for 15 minutes in the clinic before you are allowed to go home.
You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any symptoms you may be experiencing, and you will also record your body temperature.
Study Visits:
On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to the flu virus.
On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will be reviewed. If you cannot come to the clinic, a member of the research staff will call you to review this information. This phone call will take 15-30 minutes.
On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to the flu virus.
On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit, you may have your blood drawn at a local clinic. You will then mail the blood to the study doctor in a pre-paid envelope.
On Month 6, you will be called and asked about any side effects you may have experienced. This phone call will take 15-30 minutes.
Length of Study:
You will be considered off study after the Month 6 phone call. You will be taken off-study early if intolerable side effects or an allergic reaction occurs.
This is an investigational study. TIV, pegylated interferon, and interferon are FDA approved and commercially available. At this time, the use of pegylated interferon and standard interferon with TIV is only being used for research.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIV | Experimental | Biological: Influenza Vaccine Trivalent Inactivated (TIV)TIV (Influenza Vaccine Trivalent Inactivated) alone |
| TIV + PEGrIFN-α | Experimental | Biological: Influenza Vaccine Trivalent Inactivated (TIV), Drug: Pegylated interferon (PEGrIFN-α, Pegasys)TIV + Pegylated Interferon |
| TIV + IFNα | Experimental | Biological: Influenza Vaccine Trivalent Inactivated (TIV), Drug: Interferon (IFNα, Roferon-A)TIV + Interferon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Patients with histologically or cytologically confirmed diagnosis of chronic lymphocytic leukemia according to established guidelines.
- Patients with Rai stages 0 to 4.
- Age >/= 18 years old.
- If patients have been treated with antineoplastic therapy, it must have been finished 3 months or longer prior to enrollment.
Key exclusion criteria (19 listed)
- Concurrent serious medical illness in the opinion of Principle Investigator that could potentially interfere with protocol compliance.
- Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival is 5 years).
- History of known chronic viral infections within 12 months, including HIV and Hepatitis B or Hepatitis C. A screening for hepatitis or HIV will not be performed for this study.
- Positive screening pregnancy test within 2 weeks in non-menopausal women or breast-feeding.
- Patients with known allergy to either vaccine or interferon preparation.
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 |
|---|---|---|
| Influenza Vaccine Trivalent Inactivated (TIV)15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28. | Biological | TIV, TIV + IFNα, TIV + PEGrIFN-α |
| Pegylated interferon (PEGrIFN-α, Pegasys)Also: Pegasys, Peginterferon alfa-2a180 μg (0.5 ml) before receiving TIV, through a needle under the skin. | Drug | TIV + PEGrIFN-α |
| Interferon (IFNα, Roferon-A)Also: Roferon-A, Interferon alfa-2a3 million units (0.5 ml) before receiving TIV, through a needle under the skin. | Drug | TIV + IFNα |
Primary outcome
Immunogenicity rate
Time frame: Day 1, 8, 28, 56 and 6 Months
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 3 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Amar Safdar, MD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Influenza Vaccine Trivalent Inactivated (TIV), Pegylated interferon (PEGrIFN-α, Pegasys) and Interferon (IFNα, Roferon-A) in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center.
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 12 inclusion and 19 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 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immunogenicity rate (time frame: Day 1, 8, 28, 56 and 6 Months). 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 3 Aug 2012.