Avascular NecrosisNCT00719147
AVN of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
An observational study of Avascular Necrosis and Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Avascular Necrosis, Acute Lymphoblastic Leukemia
- What is being tested?
- MRI and Functional Status and Symptom Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
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.
Read the 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:
- 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.
- 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.
- 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 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.
- Conditions
- Avascular Necrosis, Acute Lymphoblastic Leukemia
- Being tested
- MRI, Functional Status and Symptom Questionnaire
- Medical subject headings
- Osteonecrosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Not performed for study purposes, MRI will be done as part of routine clinical visit. Findings will be used for study.
Functional Status and Symptom QuestionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: MRI; Other: Functional Status and Symptom Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation
Measured: 7-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2001
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Howard, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719147
- Sponsor's protocol ID
- AVN2
- Status last verified
- Sep 2011
- First submitted
- 17 Jul 2008
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
- ClinicalTrials.gov ID
- NCT00719147
- Acronym / sponsor ID
- AVN2
- Conditions
- Avascular Necrosis, Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jul 2001
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: MRI, Other: Functional Status and Symptom Questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRINot performed for study purposes, MRI will be done as part of routine clinical visit. Findings will be used for study. | Procedure or surgery | 1 |
| Functional Status and Symptom QuestionnaireQuestionnaire | Other | 1 |
Primary outcome
To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation
Time frame: 7-8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
- St. Jude Children's Research HosiptalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Howard, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis and Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation (time frame: 7-8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.