Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Not Recruiting

Trial ID: NCT00408005


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)


Inclusion Criteria:

   - T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on

   - 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


      - 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

   - 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


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

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