WT1 for the Detection of Minimal Residual Disease

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179829
• Other study ID #: BMT 0399
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2005
• Last updated: January 14, 2008
• Start date: February 1999
• Est. completion date: April 2006

Study information

• Verified date: January 2008
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Neoplasm, Residual

Intervention

Procedure:
• WT 1 Testing

Locations

Country	Name	City	State
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.
Primary	To determine longitudinally its value as a marker for minimal residual disease (MRD) and its correlation to leukemia free survival after bone marrow transplantation.
Primary	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.