Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT00558519


RATIONALE: 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. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.

Official Title

An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL)

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Jason Gotlib

Professor of Medicine (Hematology)


Eligibility Criteria:

   1. Diagnosis

      1. Newly diagnosed patients with either B-precursor or T-precursor acute
      lymphoblastic leukemia (WHO criteria). Burkitt type leukemia as defined per
      protocol is not eligible. Patients known to have Ph+ ALL at time of diagnosis are
      not eligible.

      2. CALGB patients entered on CALGB 10403 who are later found to meet the following
      criteria for Ph+ ALL should have treatment on this trial discontinued and should
      be encouraged to enroll on CALGB 10001 or its successor trial:

         - BCR-ABL fusion transcript determined by FISH or RT-PCR

         - t(9;22)(q34;q11) or variant determined by cytogenetics

   Non-CALGB study participants who are later found to be Ph+ should have treatment on
   this trial discontinued and should be encouraged to enroll on an appropriate clinical
   trial specifically designed for Ph+ ALL.

   2. Age: 16 - 39 years

   3. ECOG Performance Status 0-2

   4. Patients with Down Syndrome are excluded from this study due to the likelihood of
   excessive toxicity resulting. These patients should be treated in consultation with a
   pediatric oncologist.

   5. Prior Therapy - No prior therapy except for limited treatment with corticosteroids or
   hydroxyurea and a single dose of intrathecal cytarabine.

      1. No prior therapy for acute leukemia except emergency therapy (corticosteroids or
      hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure
      due to leukemic infiltration of the kidneys. When indicated, leukapheresis or
      exchange transfusion is recommended to reduce the WBC.

      2. Single-dose intrathecal cytarabine is allowed prior to registration or prior to
      initiation of systemic therapy 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. Systemic chemotherapy must begin within 72 hours of this
      intrathecal therapy.

      3. Patients receiving prior steroid therapy are eligible for study. The dose and
      duration of previous steroid therapy should be carefully documented on case
      report forms.


radiation: radiation therapy

drug: cyclophosphamide

drug: cytarabine

drug: daunorubicin hydrochloride

drug: dexamethasone

drug: doxorubicin hydrochloride

drug: mercaptopurine

drug: methotrexate

drug: pegaspargase

drug: thioguanine

drug: vincristine sulfate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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