WT1 for the Detection of Minimal Residual Disease
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
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 leukemia
Started Feb 1999
Typical duration for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFebruary 4, 2025
January 1, 2025
7.2 years
September 10, 2005
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morris Kletzel, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 16, 2005
Study Start
February 1, 1999
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
February 4, 2025
Record last verified: 2025-01