AVN of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719147
• Other study ID #: AVN2
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: September 26, 2011
• Start date: July 2001
• Est. completion date: July 2005

Study information

• Verified date: September 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation.

Description:

Patients with acute lymphoblastic leukemia enrolled on the St. Jude Children's Research Hospital front-line Acuter Lymphoblastic Leukemia protocol, Total XIIIB or the front-line Non Hodgkin's Lymphoma protocol NHL13 from 11/94 to 6/98, in continuous complete remission or who have an MRI-confirmed diagnosis of AVN of the hip or knee prior to relapse are eligible for this study.

Patients will receive an MRI examination of the hips and knees based on the following:

1. Patients who have no previous diagnosis of AVN and no previous MRI of the hips and knees will have a MRI of the hips and knees after the patient completes therapy.

2. Patients who have no previous diagnosis of AVN and have had a previous MRI of the hips and knees after completion of therapy will need no further imaging. If the patient had not completed therapy at the time of the MRI, she/he will undergo MRI of hips and knees.

3. For patients with a previous AVN diagnosis and previous MRI of the hips and knees*, the first MRI which showed AVN will be used and plain radiographs of affected joints, if not already done, will be done.

*If a previous MRI showed AVN, but plain radiographs were not performed, the patient will have MRI and plain radiographs after enrollment in AVN2. If MRI of both hips and both knees with plain radiographs of affected joints have been done previously, the patient requires no further imaging but still will be enrolled on the study for the purpose of analysis.

4. Patients who have a previous diagnosis of AVN and no previous MRI of the hips and knees will have a MRI evaluation of the hips and knees and plain radiographs of affected joints.

Patients will be referred to a bone doctor as needed.

Patients will be asked to fill out a questionnaire (which will take approximately 10 minutes) about any pain or problems that have with their hips and knees.

If patients have already agreed to take part in the PGEN4 or PGEN5 research study; studies researching how genes affect the way the body uses certain chemotherapy drugs, genetic information from the blood tests done as part of those studies will be used to see if it can be predicted who has the greatest risk of AVN.

All study tests will be done on one day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with acute lymphoblastic leukemia enrolled on the SJCRH front-line ALL protocol, TOTAL XIIIB or the front-line NHL protocol NHL13 from 11/94 to 6/98.

• Patients must be in continuous complete remission or have an MRI-confirmed diagnosis of AVN of the hip or knee prior to relapse.

Exclusion Criteria:

Study Design

N/A

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Avascular Necrosis
• Leukemia, Lymphoid
• Necrosis
• Osteonecrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• MRI
Not performed for study purposes, MRI will be done as part of routine clinical visit. Findings will be used for study.

Other:
• Functional Status and Symptom Questionnaire
Questionnaire

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation		7-8 years	Yes

External Links

•   St. Jude Children's Research Hosiptal