Clinical trial · Interventional
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult B Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Childhood B Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calaspargase Pegol-mknl | Drug | Calaspargase Pegol | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin Hydrochloride | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (combination chemotherapy)
- description
- Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.
- interventionNames
- Drug: Calaspargase Pegol-mknl
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Drug: Doxorubicin Hydrochloride
- Other: Laboratory Biomarker Analysis
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Pegaspargase
- Other: Pharmacological Study
- Drug: Prednisone
- Radiation: Radiation Therapy
- Drug: Thioguanine
- Drug: Vincristine Sulfate
- type
- ACTIVE_COMPARATOR
- label
- Arm II (combination chemotherapy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be eligible for and enrolled on AALL08B1 or the successor classification study * Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization \[WHO\] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia) * White blood cell (WBC) \>= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids * Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy * Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented * Pregnancy tests with a negative result must be obtained in all post-menarchal females * Lactating females must agree that they will not breastfeed a child while on this study Exclusion Criteria: * Patients with Down syndrome are excluded from this study * Patients with testicular leukemia at diagnosis are excluded from this study * Pregnant female patients are excluded from this study
References
Publications (1)
- DERIVEDSchore RJ, Devidas M, Bleyer A, Reaman GH, Winick N, Loh ML, Raetz EA, Carroll WL, Hunger SP, Angiolillo AL. Plasma asparaginase activity and asparagine depletion in acute lymphoblastic leukemia patients treated with pegaspargase on Children's Oncology Group AALL07P4. Leuk Lymphoma. 2019 Jul;60(7):1740-1748. doi: 10.1080/10428194.2018.1542146. Epub 2019 Jan 10. PMID 30626253