LeukemiaPhase 2/3NCT00179829
WT1 for the Detection of Minimal Residual Disease
A Phase 2/3 study testing WT 1 Testing in people with Leukemia and Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients. Read more about this study
- Who is it for?
- Ages Up to 21 years
- What is being tested?
- WT 1 Testing
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Apr 2006
- Phase
- Phase 2/3
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age less than 21 years of age.
- Patients with the following diseases: Acute lymphoblastic Leukemia (ALL) at the time of diagnoses or relapse, Acute non-lymphoblastic leukemia (ANLL) at diagnosis or after relapse and Chronic Myelogenous leukemia in chronic or accelerated phase.
- Patients will be eligible for any of the available treatment protocols or protocols for stem cell transplantation, regardless of the source of stem cells.
- Patients or legal guardians will sign an Institutional Review Board (IRB) approved informed consent.
- Patients will have venous access or peripheral vein for sampling.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Detection of Minimal Residual Disease in Newly Diagnosed Patients With Leukemia and Those Who Undergo a Bone Marrow Transplant Using the Wilms Tumor Suppressor Gene (WT1) as a Marker By RT-PCR
The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.
Read the detailed description
Patients with acute Leukemia may have a large number of leukemic cells at the time that leukemia is evident clinically. At the time that we determine that a patient is in complete remission (CR) the patient may still have leukemic cells present in smaller quantities. One of the most important factors in the successful treatment of patients with leukemia is the ability to determine if the eradication of leukemia has been achieved. The determination of Minimal Residual Disease may be important in the determination of the therapy that a given patient will receive as determined by the level of residual disease.
WT1 gene function and expression. The WT1 gene is a candidate gene for Wilms tumor, which is thought to arise as a result from inactivation of both alleles of the WT1 gene located at chromosome 11p13. The WT1 gene has been considered a tumor suppressor gene because intragenic deletions or mutations are found in tumors, germline mutations have been found in-patients with leukemia, and mediates growth suppression of Wilms tumor cells expressing a WT1 splicing variant.
- Being tested
- WT 1 Testing
- Keywords
- leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia
- Medical subject headings
- Leukemia, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WT 1 TestingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.
To determine longitudinally its value as a marker for minimal residual disease (MRD) and its correlation to leukemia free survival after bone marrow transplantation.
To assess the presence of the WT1 gene in newly diagnosed patients with leukemia (ALL, ANLL) at the time of diagnoses and during the course of their treatment and correlate it with leukemia free survival (LFS) and relapse.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 1999
- Primary completionApr 2006
- Study completionApr 2006
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Kletzel, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179829
- Sponsor's protocol ID
- BMT 0399
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2005
- Last updated
- 4 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Minimal Residual Disease in Newly Diagnosed Patients With Leukemia and Those Who Undergo a Bone Marrow Transplant Using the Wilms Tumor Suppressor Gene (WT1) as a Marker By RT-PCR
- ClinicalTrials.gov ID
- NCT00179829
- Acronym / sponsor ID
- BMT 0399
- Keywords
- leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Feb 1999 (actual)
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 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.
The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.
Detailed description
Patients with acute Leukemia may have a large number of leukemic cells at the time that leukemia is evident clinically. At the time that we determine that a patient is in complete remission (CR) the patient may still have leukemic cells present in smaller quantities. One of the most important factors in the successful treatment of patients with leukemia is the ability to determine if the eradication of leukemia has been achieved. The determination of Minimal Residual Disease may be important in the determination of the therapy that a given patient will receive as determined by the level of residual disease.
WT1 gene function and expression. The WT1 gene is a candidate gene for Wilms tumor, which is thought to arise as a result from inactivation of both alleles of the WT1 gene located at chromosome 11p13. The WT1 gene has been considered a tumor suppressor gene because intragenic deletions or mutations are found in tumors, germline mutations have been found in-patients with leukemia, and mediates growth suppression of Wilms tumor cells expressing a WT1 splicing variant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age less than 21 years of age.
- Patients with the following diseases: Acute lymphoblastic Leukemia (ALL) at the time of diagnoses or relapse, Acute non-lymphoblastic leukemia (ANLL) at diagnosis or after relapse and Chronic Myelogenous leukemia in chronic or accelerated phase.
- Patients will be eligible for any of the available treatment protocols or protocols for stem cell transplantation, regardless of the source of stem cells.
- Patients or legal guardians will sign an Institutional Review Board (IRB) approved informed consent.
- Patients will have venous access or peripheral vein for sampling.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WT 1 Testing | Procedure or surgery | – |
Primary outcome
To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.
To determine longitudinally its value as a marker for minimal residual disease (MRD) and its correlation to leukemia free survival after bone marrow transplantation.
To assess the presence of the WT1 gene in newly diagnosed patients with leukemia (ALL, ANLL) at the time of diagnoses and during the course of their treatment and correlate it with leukemia free survival (LFS) and relapse.
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 4 Feb 2025.
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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.
Morris Kletzel, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing WT 1 Testing in people with Leukemia and Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 5 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 4 Feb 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.. The study lists 3 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 4 Feb 2025.