Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: dactinomycin; sargramostim; carmustine; cyclophosphamide; cytarabine; daunorubicin hydrochloride; doxorubicin hydrochloride; etoposide; mercaptopurine; methotrexate; mitoxantrone hydrochloride; pegaspargase; prednisone; vincristine sulfate; radiation therapy
Intervention MeSH terms: Cytarabine; Dactinomycin; Prednisone; Cyclophosphamide; Carmustine; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Daunorubicin; Mitoxantrone; Mercaptopurine; Pegaspargase; Sargramostim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: blastic phase chronic myelogenous leukemia; untreated adult acute lymphoblastic leukemia; chronic myelogenous leukemia, BCR-ABL1 positive; T-cell adult acute lymphoblastic leukemia; B-cell adult acute lymphoblastic leukemia; stage I adult lymphoblastic lymphoma; stage II adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic
      leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.

      PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and
      comparing them to see how well they work in treating adults with acute lymphoblastic
      leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of one of the following malignancies:

               -  Acute lymphoblastic leukemia (ALL) of B- or T-cell lineage

               -  Philadelphia chromosome-positive ALL eligible

               -  Lymphoblastic lymphoma

               -  Chronic myelogenous leukemia in lymphoid blast crisis

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 20-100%

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin no greater than 2.0 mg/dL

          -  Glucocorticoids for higher bilirubin allowed prior to entry, at principal
             investigator's discretion

        Renal:

          -  Creatinine no greater than 2.0 mg/dL

          -  Glucocorticoids or renal radiotherapy for higher creatinine allowed prior to entry, at
             principal investigator's discretion

        Cardiovascular:

          -  Left ventricular ejection fraction at least 50%

        Other:

          -  Not pregnant

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior biologic therapy

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  No prior endocrine therapy

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  No prior surgery