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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


Phase 2/Phase 3
N/A
21 Years
Not Enrolling
Both
Leukemia, Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.

Principal Investigator

Morris Kletzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

BMT 0399

NCT ID:

NCT00179829

Start Date:

February 1999

Completion Date:

April 2006

Related Keywords:

  • Leukemia
  • Cancer
  • leukemia
  • acute lymphocytic leukemia
  • chronic myelogenous leukemia
  • acute myelogenous leukemia
  • Leukemia
  • Neoplasm, Residual

Name

Location

Children's Memorial HospitalChicago, Illinois  60614