Phase 1
N=104
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
Acute Lymphoblastic Leukemia · Adult B Acute Lymphoblastic Leukemia · Childhood B Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00866307 ↗Enrolled (actual)
104
Serious AEs
8.0%
Results posted
Dec 2016
Primary outcome: Primary: AALL08P1 Safety Outcome — 50.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cyclophosphamide (Drug); Cytarabine (Drug); Daunorubicin Hydrochloride (Drug); Dexamethasone (Drug); Doxorubicin Hydrochloride (Drug); Laboratory Biomarker Analysis (Other); Mercaptopurine (Drug); Methotrexate (Drug); Pegaspargase (Drug); Prednisone (Drug); Prophylactic Cranial Irradiation (Radiation); Thioguanine (Drug); Vincristine Sulfate (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AALL08P1 Safety Outcome |
50.0 | — |
| PRIMARY AALL08P1 Feasibility Outcome |
53.3 | — |
Summary
This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.
Eligibility Criteria
Inclusion Criteria
- Patients must be eligible for and enrolled on AALL03B1 or the successor classification study
- Patients must have newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL)
- WBC criteria
- Age 1.00-9.99 years: WBC >= 50,000/uL
- Age 10.00 - 30.99 years: Any WBC
- Prior steroid therapy: Any WBC
- Patients with testicular leukemia: Any WBC
- 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; 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 study; the dose and duration of previous steroid therapy should be carefully documented
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
- Pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study
- Patients with Down syndrome (DS) are ineligible since excessive toxicities and death have been noted for those enrolled on AALL0232 receiving the prednisone/Capizzi methotrexate (PC) arm of treatment, which is the backbone regimen for the current study
Data sourced from ClinicalTrials.gov (NCT00866307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.