CLLKLL3NCT01397916
Indoleamine 2,3-dioxygenase (IDO) Activity in Patients With Chronic Lymphocytic Leukemia (CLL)
An observational study of CLL, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied. Read more about this study
- Who is it for?
- Ages 15 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- CLL
- How many people
- 73 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2010to Dec 2010
- Phase
- Observational
- 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 15 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with CLL
Who may be able to join
- Patients with CLL and lymphocyte count > 10 x 109/l
Who cannot join
- Acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Activity of Indoleamine 2,3-dioxygenase in Patients With Chronic Lymphocytic Leukemia (CLL)
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied.
Read the detailed description
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL)is studied in patients and healthly controls.
- Conditions
- CLL
- Keywords
- CLL, IDO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CLL-patients | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IDO activity and expression measured by kynurenine/tryptophan ratio in serum and by PCR in peripheral blood mononuclear cells.
Indoleamine 2,3 -dioxygenase (IDO) activity in patients with CLL was measured by the serum kynurenine/tryptophan (kyn/trp) ratio and - the expression of INDO (encoding IDO enzyme) and INDOL1 (encoding IDO2 enzyme) genes in peripheral blood mononuclear cells via TaqMan real-time PCR.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MSinisalo, Tampere University Hospital
- Investigators
- Marjatta Sinisalo, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397916
- Sponsor's protocol ID
- CLL-IDO
- Acronym
- KLL3
- Status last verified
- Feb 2022
- First submitted
- 18 May 2010
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Activity of Indoleamine 2,3-dioxygenase in Patients With Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT01397916
- Acronym / sponsor ID
- KLL3 / CLL-IDO
- Conditions
- CLL
- Keywords
- CLL, IDO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jul 2011 (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 Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied.
Detailed description
The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL)is studied in patients and healthly controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLL-patients | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CLL
Key inclusion criteria (1 listed)
- Patients with CLL and lymphocyte count > 10 x 109/l
Key exclusion criteria (1 listed)
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IDO activity and expression measured by kynurenine/tryptophan ratio in serum and by PCR in peripheral blood mononuclear cells.
Time frame: 3 months
Indoleamine 2,3 -dioxygenase (IDO) activity in patients with CLL was measured by the serum kynurenine/tryptophan (kyn/trp) ratio and - the expression of INDO (encoding IDO enzyme) and INDOL1 (encoding IDO2 enzyme) genes in peripheral blood mononuclear cells via TaqMan real-time PCR.
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 19 Apr 2024.
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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.
Marjatta Sinisalo, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL, run by Tampere University Hospital at 1 site in Finland.
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 1 inclusion and 1 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 19 Apr 2024. 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 Finland. 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 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?
IDO activity and expression measured by kynurenine/tryptophan ratio in serum and by PCR in peripheral blood mononuclear cells. (time frame: 3 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 19 Apr 2024.