Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: cyclophosphamide; cytarabine; daunorubicin hydrochloride; dexamethasone; doxorubicin hydrochloride; mercaptopurine; methotrexate; pegaspargase; thioguanine; vincristine sulfate; radiation therapy
Intervention MeSH terms: Cytarabine; Dexamethasone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Daunorubicin; Mercaptopurine; Pegaspargase; Thioguanine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 318.0
Sex: All
Minimum age: 16 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia

Summary:

      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.
    

Eligibility criteria:

        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.