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Enzyme
SC-PEG Asparaginase vs. Oncaspar for Acute Lymphoblastic Leukemia
Phase 2
Waitlist Available
Led By Andrew Place, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of ALL or lymphoblastic leukemia
Be younger than 65 years old
Must not have
History of previous malignancy
Have received any chemotherapy or radiotherapy for previous malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
Who is the study for?
This trial is for children and adolescents with a confirmed diagnosis of ALL or lymphoblastic leukemia who haven't had previous treatments, except possibly short-term steroids, one dose of IT cytarabine, or urgent radiation. It's not for those with uncontrolled illnesses, pregnant/breastfeeding individuals, HIV-positive patients, anyone on other experimental drugs or extensive prior steroid use.
What is being tested?
The study compares SC-PEG Asparaginase to Oncaspar in treating pediatric acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. Researchers want to see if SC-PEG's side effects are similar to Oncaspar when given every three weeks versus two and if it helps improve cure rates by adjusting treatment based on minimal residual disease levels.
What are the potential side effects?
Potential side effects include reactions at the injection site, liver problems, blood clotting issues, pancreatitis (inflammation of the pancreas), allergic reactions and lowered blood cell counts which can increase infection risk. The severity can vary from mild to serious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with acute lymphoblastic leukemia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer before.
Select...
I have had chemotherapy or radiotherapy for another cancer.
Select...
I do not have any uncontrolled illnesses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Induction and Post-Induction Nadir Serum Asparaginase Activity Level
Number of Participants With Asparaginase-Related Toxicity
Secondary study objectives
Feasibility of Prospective Screening for ABGD
Feasibility of Prospective Screening for Genetic Abnormalities
Ergocalciferol
+4 moreTrial Design
2Treatment groups
Active Control
Group I: SC-PEG (Arm A)Active Control1 Intervention
Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Group II: Oncaspar (Arm B)Active Control1 Intervention
Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Find a Location
Who is running the clinical trial?
ShireIndustry Sponsor
456 Previous Clinical Trials
97,038 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,760 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
352,857 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: SC-PEG (Arm A)
- Group 2: Oncaspar (Arm B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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