Gene Therapy Clinical Trials
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- radiation: radiation therapy
- drug: cyclophosphamide
- drug: cytarabine
- drug: daunorubicin hydrochloride
- drug: dexamethasone
- drug: doxorubicin hydrochloride
- drug: methotrexate
- drug: pegaspargase
- drug: prednisone
- drug: vincristine sulfate
- drug: thioguanine
- other: laboratory biomarker analysis
- other: pharmacological study
- drug: Calaspargase Pegol-mknl
- drug: Mercaptopurine
Eligibility
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
Ages Eligible for Study
2 Years - 30 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting