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SC-PEG Asparaginase vs. Oncaspar for Acute Lymphoblastic Leukemia
Study Summary
This trial is studying a new form of asparaginase to treat children with leukemia with the hope of reducing side effects and increasing cure rates.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had cancer before.I do not have any uncontrolled illnesses.I have only had steroids, one dose of IT cytarabine, or emergency radiation for life-threatening masses.I have taken corticosteroids for more than 7 days in the last month or more than 28 days in the last 6 months.I have been diagnosed with acute lymphoblastic leukemia.I have had chemotherapy or radiotherapy for another cancer.
- Group 1: SC-PEG (Arm A)
- Group 2: Oncaspar (Arm B)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this clinical trial only available to people over the age of 55?
"applicants who wish to participate in this trial must be between the ages of 1 and 21 years old. There are 683 other clinical trials for individuals under 18 while there are 2583 research studies available for patients over 65."
Is Arm A the only clinical trial to use SC-PEG?
"SC-PEG (Arm A) was first researched in 2007 at Alliance for Childhood Diseases/Cure 4 the Kids Foundation. Since then, there have been 47 completed studies with an additional 47 ongoing clinical trials; a large proportion of which are based in Boston, Massachusetts."
To what extent has Arm A's SC-PEG been federally approved?
"SC-PEG (Arm A) is at a Phase 2 level, meaning that while there is some data affirming its safety, there is no evidence yet of efficacy. Therefore, it was given a score of 2."
Are there different hospitals or research centers conducting this experiment within state borders?
"Currently, there are 9 active clinical trial sites for this medication. They are located in Boston, New york, Hamilton and 6 other places. If you choose to participate in this study, try to select the location closest to you to cut down on travel time."
What are the goals of this clinical trial?
"This clinical trial's primary outcome is the serum Asparaginase activity level during and after treatment, which will be evaluated over a period of about 30 weeks. Secondary outcomes include the correlation between apoptotic/anti-apoptotic proteins and response to treatment, rates of complete remission, relapse, induction death, remission death, and second malignant neoplasms in participants, and rates of relapse, remission death and second malignant neoplasm in participants with high minimal residual disease (MRD) or high risk cytogenetics who are treated with a more intensified regimen."
Are there any slots in this experiment still available for participants?
"Enrollment for this clinical trial has been closed. The study was originally posted on 6/1/2012 but was last updated on 9/19/2022. Currently, there are 2978 trials enrolling patients with leukemia and 47 trials enrolling participants for SC-PEG (Arm A)."
Are there specific medical criteria for volunteers in this research program?
"In order to qualify for this study, potential participants must be between 365 days and 21 years old, have a confirmed diagnosis of acute lymphoblastic leukemia or lymphoblastic leukemia, and cannot have received any prior therapy except short courses of corticosteroids, a single dose of IT cytarabine or emergent radiation to the mediastinum or other life-threatening masses."
How many people are eligible to participate in this experiment?
"Unfortunately, this particular clinical trial is not recruiting patients at the moment. The study was originally posted on June 1st, 2012 and updated September 19th, 2022. Although this specific study may not be looking for participants, there are 2978 other trials actively recruiting patients with leukemia and 47 trials specifically for SC-PEG (Arm A)."
What is the primary condition that SC-PEG (Arm A) has been used to address?
"SC-PEG (Arm A) can be used to treat hypersensitivity, combination chemotherapy, and acute lymphoblastic leukemia."
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