WT1 for the Detection of Minimal Residual Disease

This study has been completed.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179829
First received: September 10, 2005
Last updated: January 14, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Leukemia
Cancer
Procedure: WT 1 Testing
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

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.

Estimated Enrollment: 50
Study Start Date: February 1999
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179829

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179829     History of Changes
Other Study ID Numbers: BMT 0399
Study First Received: September 10, 2005
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
leukemia
acute lymphocytic leukemia
chronic myelogenous leukemia
acute myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014