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Enzyme

SC-PEG Asparaginase vs. Oncaspar for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
Select...
I have been diagnosed with acute lymphoblastic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Induction and Post-Induction Nadir Serum Asparaginase Activity Level
Number of Participants With Asparaginase-Related Toxicity
Secondary outcome measures
Feasibility of Prospective Screening for ABGD
Feasibility of Prospective Screening for Genetic Abnormalities
Ergocalciferol
+4 more

Trial 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
97,052 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,406 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,166 Total Patients Enrolled

Media Library

Oncaspar (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT01574274 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: SC-PEG (Arm A), Oncaspar (Arm B)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Oncaspar Highlights & Side Effects. Trial Name: NCT01574274 — Phase 2
Oncaspar (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01574274 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI
Recent research and studies
~19 spots leftby Mar 2025