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AVN of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
This study is ongoing, but not recruiting participants.
Sponsored by: St. Jude Children's Research Hospital
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00719147
  Purpose

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.


Condition Intervention
Avascular Necrosis
Acute Lymphoblastic Leukemia
Procedure: MRI
Other: Functional Status and Symptom Questionnaire

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Osteonecrosis
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Prednisone
U.S. FDA Resources
Study Type: Observational
Official Title: Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation [ Time Frame: 7-8 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 170
Study Start Date: July 2001
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 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

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719147

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Scott Howard, MD St. Jude Children's Research Hospital
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: St. Jude Children's Research Hospital ( Scott Howard, MD )
Study ID Numbers: AVN2
Study First Received: July 17, 2008
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00719147  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Dexamethasone
Prednisone
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Osteonecrosis
Hematologic Neoplasms
Hematologic Diseases
Bone Diseases
Body Weight
Leukemia
Lymphatic Diseases
Necrosis
Musculoskeletal Diseases
Lymphoproliferative Disorders
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Pathologic Processes
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009