Chronic Lymphocytic LeukemiaPhase 1NCT00233506
A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
A Phase 1 study testing CpG 7909 in people with Chronic Lymphocytic Leukemia, run by University of Iowa at 2 sites in United States.
Trial summary
CpG has the potential to stimulate the immune system this study will evaluate the safety of CpG given sub-q or IV purpose is to measure biological changes in CLL cells after receiving CpG 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?
- CpG 7909
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Jun 2011
- Phase
- Phase 1
- 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
- Diagnosis of CLL
- CLL previously treated
- Hemoglobin >/= 10
- Platelets >/= 50,000
- Neutrophils >= 1,000 -
Who cannot join
- patients with brain mets
- patients with autoimmune disease
- patients on corticosteroids or immunosuppressants
- patients with uncontrolled intercurrent illness
- pregnant women
- HIV patients receiving combination anti-retroviral therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
- CpG has the potential to stimulate the immune system
- this study will evaluate the safety of CpG given sub-q or IV
- purpose is to measure biological changes in CLL cells after receiving CpG
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- CpG 7909
- Keywords
- CpG 7909, 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.
CpG 7909Drug
| Study group | Role | What they receive |
|---|---|---|
| CPG 7909 IV | Experimental | Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral). Receives: Drug: CpG 7909 |
| CPG 7909 SQ | Experimental | Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites. Receives: Drug: CpG 7909 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
Measured: at study completion
Secondary outcomes (1)
response
Measured: at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2011
- Study completionJun 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 University of IowaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Pfizer, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Link, Brian K, University of Iowa
- Investigators
- Brian Link, MD, Principal investigator, UIHCClive Zent, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233506
- Sponsor's protocol ID
- 200402002
- Status last verified
- Feb 2017
- First submitted
- 3 Oct 2005
- Last updated
- 6 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00233506
- Acronym / sponsor ID
- 200402002
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CpG 7909, CLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Mayo Clinic, Pfizer, National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Oct 2005 (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.
- CpG has the potential to stimulate the immune system
- this study will evaluate the safety of CpG given sub-q or IV
- purpose is to measure biological changes in CLL cells after receiving CpG
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPG 7909 IV | Experimental | Drug: CpG 7909Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral). |
| CPG 7909 SQ | Experimental | Drug: CpG 7909Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CLL
- CLL previously treated
- Hemoglobin >/= 10
- Platelets >/= 50,000
- Neutrophils >= 1,000 -
Key exclusion criteria (6 listed)
- patients with brain mets
- patients with autoimmune disease
- patients on corticosteroids or immunosuppressants
- patients with uncontrolled intercurrent illness
- pregnant women
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 |
|---|---|---|
| CpG 7909 | Drug | CPG 7909 IV, CPG 7909 SQ |
Primary outcome
maximum tolerated dose
Time frame: at study completion
1 secondary outcome
response
Time frame: at end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
Brian Link, MD principal investigator
UIHC
Clive Zent, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CpG 7909 in people with Chronic Lymphocytic Leukemia, run by University of Iowa at 2 sites 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 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: at study completion). 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 6 Feb 2017.