Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Asparaginase
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Daunorubicin Hydrochloride
  • Drug: Dexamethasone
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Nelarabine
  • Drug: Pegaspargase
  • Drug: Prednisone
  • Radiation: Radiation Therapy
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate

Phase:

Phase 3

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

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
Pediatric Hematology/Oncology
6504978953
Not Recruiting