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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Not Recruiting
Trial ID: NCT00408005
Purpose
This randomized phase III trial is studying different combination chemotherapy regimens and
their side effects and comparing how well they work in treating young patients with newly
diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. 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. It is not yet known which combination chemotherapy regimen is
more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic
lymphoma. After a common induction therapy, patients were risk assigned and eligible for one
or both post-induction randomizations: Escalating dose Methotrexate versus High Dose
Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation
therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low
Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at
diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction
therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were
all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High
Risk and induction failures. Standard risk patients did not receive nelarabine, High risk
T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures
were assigned to receive Nelarabine.
Official Title
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on
AALL0434
- Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL)
stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a
diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or
evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and
express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7,
CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional
markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99
will be assessed for expression; cases with uncertain expression will receive
additional review within the appropriate Children's Oncology Group (COG) reference
laboratory
- T-NHL PATIENTS:
- For T-NHL patients with tissue available for flow cytometry, the criterion for
diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e.
paraffin blocks), the methodology and criteria for immunophenotypic analysis to
establish the diagnosis of T-NHL defined by the submitting institution will be
accepted
- Prior therapy restrictions
- Patients shall have had no prior cytotoxic chemotherapy with the exception of
steroids and/or IT cytarabine
- IT 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 IT therapy
- Patients diagnosed as having T-NHL or T-ALL with respiratory distress or
hyperleukocytosis may require steroids prior to the initiation of additional
systemic therapy; they are eligible for AALL0434 and will be stratified, based on
the initial complete blood count (CBC); steroid pretreatment may alter the risk
group assessment; if the T-ALL patient's clinical status precludes a lumbar
puncture within 48 hours of the initiation of steroid therapy, T-ALL patients
CANNOT be classified as low risk and will be Intermediate or high risk based on
the results of the day 29 marrow as above; patients with T-NHL who receive
steroid pre-treatment will be classified as high risk; the dose and duration of
previous steroid therapy should be carefully documented
- For the management of airway compromise, patients who have received emergent
chest irradiation up to 600 cGy will be eligible for this study
- Patients with a prior seizure disorder requiring anti-convulsant therapy are not
eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or
greater) peripheral neurotoxicity, as determined prior to Induction treatment by the
treating physician or a neurologist, are not eligible to receive nelarabine; these
restrictions in eligibility are designed to prevent excessive nelarabine-induced
central and peripheral neurotoxicity in at-risk patients; for the purposes of this
study, this includes any patient that has received anticonvulsant therapy to
prevent/treat seizures in the prior two years
Exclusion Criteria:
- Pregnant or lactating females are ineligible
- Patients with Down syndrome are ineligible to enroll onto this study
- For T-NHL patients the following additional exclusion criteria apply:
- B-precursor lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma
- CNS3-positive or testicular involvement
Intervention(s):
drug: daunorubicin hydrochloride
drug: asparaginase
radiation: radiation therapy
other: laboratory biomarker analysis
drug: cyclophosphamide
drug: cytarabine
drug: dexamethasone
drug: doxorubicin hydrochloride
drug: leucovorin calcium
drug: methotrexate
drug: nelarabine
drug: pegaspargase
drug: prednisone
drug: thioguanine
drug: vincristine sulfate
drug: mercaptopurine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pediatric Hematology/Oncology
6504978953