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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

No Placebo-Only Group

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 below

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I have been diagnosed with acute lymphoblastic leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer before.

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I have had chemotherapy or radiotherapy for another cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met