B-Cell Chronic Lymphocytic LeukemiaPhase 1/2NCT00302861
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
A Phase 1/2 study testing MyVax in people with B-Cell Chronic Lymphocytic Leukemia, run by Genitope Corporation.
Trial summary
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Chronic Lymphocytic Leukemia
- What is being tested?
- MyVax
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to 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
- Adult, Older adult
Who may be able to join
- Have signed a written informed consent
- B-CLL diagnosis
- Rai Stage 0, I, or II
- Previously untreated
- Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured
Who cannot join
- Anti-leukemia treatment prior to beginning immunization
- Anti-leukemia treatment other than Id-KLH during immunizations
- Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
- Pregnant or lactating
- Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
- Participation in any other clinical trial in which an investigational agent is administered
About this study
Official title: Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Being tested
- MyVax
- Keywords
- B-Cll
- 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.
MyVaxBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with positive humoral immune responses
Safety and toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Genitope Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Kipps, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302861
- Sponsor's protocol ID
- 2005-11
- Status last verified
- Mar 2008
- First submitted
- 13 Mar 2006
- Last updated
- 18 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
- ClinicalTrials.gov ID
- NCT00302861
- Acronym / sponsor ID
- 2005-11
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Keywords
- B-Cll
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 86 participants
- Lead sponsor
- Genitope CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 15 Mar 2006 (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.
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have signed a written informed consent
- B-CLL diagnosis
- Rai Stage 0, I, or II
- Previously untreated
- Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured
Key exclusion criteria (6 listed)
- Anti-leukemia treatment prior to beginning immunization
- Anti-leukemia treatment other than Id-KLH during immunizations
- Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
- Pregnant or lactating
- Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
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 |
|---|---|---|
| MyVax | Biological | – |
Primary outcome
The proportion of patients with positive humoral immune responses
Safety and toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2008.
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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.
Thomas Kipps, M.D. principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MyVax in people with B-Cell Chronic Lymphocytic Leukemia, run by Genitope Corporation.
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 6 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 18 Mar 2008. 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 stopped early. 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?
The proportion of patients with positive humoral immune responses. The study lists 2 primary outcomes in all. 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 18 Mar 2008.