LeukemiaNCT00569842
Investigation of the Cylex® ImmuKnow® Assay
An observational study of Leukemia and Non-Hodgkin's Lymphoma, run by Indiana University at 1 site in United States.
Trial summary
Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible: 1. Acute leukemia 2. Non-Hodgkin's Lymphoma 3. Chronic lymphocytic leukemia 4. Hodgkin's disease 5. Multiple myeloma 6. Myelodysplastic Syndromes 7. Myeloproliferative Disorders 8. Aplastic Anemia 9. Chronic myelogenous leukemia
Who may be able to join
- Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:
- Acute leukemia
- Non-Hodgkin's Lymphoma
- Chronic lymphocytic leukemia
- Hodgkin's disease
- Multiple myeloma
Show all 10Show fewer
- Myelodysplastic Syndromes
- Myeloproliferative Disorders
- Aplastic Anemia
- Chronic myelogenous leukemia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Universtiy Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.
- Conditions
- Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin's Disease, Multiple Myeloma, Myelodysplastic Syndromes
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndromes, Myeloproliferative Disorders, Anemia, Aplastic
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 |
|---|---|---|
| observational | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Farag, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569842
- Sponsor's protocol ID
- 0710-11/ IUCRO-0207
- Status last verified
- Sep 2014
- First submitted
- 5 Dec 2007
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Cylex® ImmuKnow® Assay
- ClinicalTrials.gov ID
- NCT00569842
- Acronym / sponsor ID
- 0710-11/ IUCRO-0207
- Conditions
- Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin's Disease, Multiple Myeloma, Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Dec 2007 (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.
Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible: 1. Acute leukemia 2. Non-Hodgkin's Lymphoma 3. Chronic lymphocytic leukemia 4. Hodgkin's disease 5. Multiple myeloma 6. Myelodysplastic Syndromes 7. Myeloproliferative Disorders 8. Aplastic Anemia 9. Chronic myelogenous leukemia
Key inclusion criteria (10 listed)
- Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:
- Acute leukemia
- Non-Hodgkin's Lymphoma
- Chronic lymphocytic leukemia
- Hodgkin's disease
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 11 Sep 2014.
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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.
Sherif Farag, MD, PhD principal investigator
Indiana University
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 Leukemia and Non-Hodgkin's Lymphoma, run by Indiana University 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 10 inclusion and 0 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 11 Sep 2014. 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.
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.
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 11 Sep 2014.