Gene Therapy Clinical Trials
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). 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), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: cyclophosphamide
- drug: cytarabine
- drug: dexamethasone
- drug: doxorubicin hydrochloride
- drug: leucovorin calcium
- drug: methotrexate
- drug: pegaspargase
- drug: thioguanine
- drug: vincristine sulfate
- other: questionnaire administration
- other: laboratory biomarker analysis
- drug: Mercaptopurine
- other: Quality-of-Life Assessment
Eligibility
Inclusion Criteria:
- B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the
classification of newly diagnosed ALL patients) prior to treatment and enrollment on
AALL0932
- Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto
AALL0932
- B-ALL patients must have an initial white blood cell count < 50,000/uL
- Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL
or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
- Note: for B-LLy patients with tissue available for flow cytometry, the criterion
for diagnosis should be analogous to B-ALL; for tissue processed by other means
(i.e. paraffin blocks), the methodology and criteria for immunophenotypic
analysis to establish the diagnosis of B-LLy defined by the submitting
institution will be accepted
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and NCI requirements for human
studies must be met
Exclusion Criteria:
- With the exception of steroid pretreatment (defined below) or the administration of
intrathecal cytarabine, patients must not have received any prior cytotoxic
chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer
diagnosed prior to initiation of protocol therapy on AALL0932
- Patients receiving prior steroid therapy may be eligible for AALL0932
- Patients with central nervous system 3 (CNS3) leukemia
- CNS status must be known prior to enrollment; (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); B-LLy patients with
CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is
recommended that intrathecal cytarabine be administered at the time of the
diagnostic lumbar puncture; this is usually done at the time of the diagnostic
bone marrow or venous line placement to avoid a second lumbar puncture; this is
allowed prior to registration; systemic chemotherapy must begin within 72 hours
of the first dose of intrathecal therapy
- B-ALL patients with testicular leukemia are not eligible for AALL0932
- For B-LLy patients the following additional exclusion criteria apply:
- T-lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma
- CNS3-positive disease or testicular involvement
- M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed
their infants
- Female patients of childbearing potential are not eligible unless a negative
pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they
have agreed to use an effective contraceptive method for the duration of their
study participation
Ages Eligible for Study
1 Year - 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
Christina Baggott
650-497-7659
Not Recruiting