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WT1 for the Detection of Minimal Residual Disease

Primary Purpose

Leukemia, Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WT 1 Testing
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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.

Sites / Locations

  • Children's Memorial Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2005
Last Updated
January 14, 2008
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00179829
Brief Title
WT1 for the Detection of Minimal Residual Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Cancer
Keywords
leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
WT 1 Testing
Primary Outcome Measure Information:
Title
To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.
Title
To determine longitudinally its value as a marker for minimal residual disease (MRD) and its correlation to leukemia free survival after bone marrow transplantation.
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris Kletzel, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States

12. IPD Sharing Statement

Learn more about this trial

WT1 for the Detection of Minimal Residual Disease

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