Leukemia, Lymphocytic, ChronicPhase 1/2NCT00038415
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
A Phase 1/2 study testing CLL vaccine using DNA plasmid vector in people with Leukemia, Lymphocytic, Chronic, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic
- What is being tested?
- CLL vaccine using DNA plasmid vector
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Jan 2005
- 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
- Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL)
- WHO performance status of 2 or less.
- A life expectancy of at least one year.
- Greater than 18 years of age.
- Availability of CLL cells which can be used for DNA extraction and processing.
- A platelet count greater than 100 x 109/l.
- Ability to provide full informed consent.
Who cannot join
- Previous chemotherapy or radiotherapy.
- Presence of a monoclonal band on serum electrophoresis.
- Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease.
- Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus.
- Presence of other serious medical condition e.g. congestive heart failure.
- Presence of other malignancies.
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- Pregnancy, lactation, or not using contraceptive measures.
- Concurrent use of other anti-cancer therapy.
- Patients allergic to tetanus vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.
Read the detailed description
OBJECTIVES:
- To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
- To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
- To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
- To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
- To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
- Conditions
- Leukemia, Lymphocytic, Chronic
- Being tested
- CLL vaccine using DNA plasmid vector
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Binet Stage A, Vaccination, Idiotypic, Genetic, Deoxyribonucleic acid, DNA
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLL vaccine using DNA plasmid vectorBiological
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Not described Receives: Biological: CLL vaccine using DNA plasmid vector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: Continuous reassessment up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2002 (estimated)
- Study startDec 2001
- Primary completionJul 2004
- Study completionJan 2005
Why it stopped: Vaccine unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, ChronicStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J. Keating, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038415
- Sponsor's protocol ID
- DM99-412
- Status last verified
- Oct 2018
- First submitted
- 30 May 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
- ClinicalTrials.gov ID
- NCT00038415
- Acronym / sponsor ID
- DM99-412
- Conditions
- Leukemia, Lymphocytic, Chronic
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Binet Stage A, Vaccination, Idiotypic, Genetic, Deoxyribonucleic acid, DNA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Vaccine unavailable.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 31 May 2002 (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 research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.
Detailed description
OBJECTIVES:
- To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
- To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
- To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
- To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
- To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: CLL vaccine using DNA plasmid vector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL)
- WHO performance status of 2 or less.
- A life expectancy of at least one year.
- Greater than 18 years of age.
- Availability of CLL cells which can be used for DNA extraction and processing.
Key exclusion criteria (9 listed)
- Previous chemotherapy or radiotherapy.
- Presence of a monoclonal band on serum electrophoresis.
- Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease.
- Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus.
- Presence of other serious medical condition e.g. congestive heart failure.
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 |
|---|---|---|
| CLL vaccine using DNA plasmid vector | Biological | Vaccine |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Continuous reassessment up to 1 year
Results and safety
The study was stopped early (reason given: Vaccine unavailable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- 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.
Michael J. Keating, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CLL vaccine using DNA plasmid vector in people with Leukemia, Lymphocytic, Chronic, run by M.D. Anderson Cancer Center 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 31 Oct 2018. 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.
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 stopped early (reason given: Vaccine unavailable.). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) (time frame: Continuous reassessment up to 1 year). 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 31 Oct 2018.