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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00719147 |
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 |
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Avascular Necrosis Acute Lymphoblastic Leukemia |
Procedure: MRI Other: Functional Status and Symptom Questionnaire |
Study Type: | Observational |
Official Title: | Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone |
Enrollment: | 170 |
Study Start Date: | July 2001 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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
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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:
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.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
Exclusion Criteria:
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United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | Scott Howard, MD | St. Jude Children's Research Hospital |
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 |
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 |
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 |