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


N/A
N/A
N/A
Not Enrolling
Both
Avascular Necrosis, Acute Lymphoblastic Leukemia

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Trial Information

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


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.


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:

-

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation

Outcome Time Frame:

7-8 years

Safety Issue:

Yes

Principal Investigator

Scott Howard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

AVN2

NCT ID:

NCT00719147

Start Date:

July 2001

Completion Date:

July 2005

Related Keywords:

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

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794