Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Condition: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin
Intervention: Cyclophosphamide; Dasatinib; Doxorubicin; Etoposide; Imatinib Mesylate; Laboratory Biomarker Analysis; Prednisone; Rituximab; Vincristine Sulfate
Intervention description: Given IV; Given PO; Given IV; Given IV; Given PO; Correlative studies; Given PO; Given IV; Given IV
Intervention MeSH terms: Prednisone; Cortisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Imatinib Mesylate; Daunorubicin; Dasatinib; Podophyllotoxin; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well etoposide, prednisone, vincristine sulfate,
      cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute
      lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as
      etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, work in
      different ways to stop the growth of cancer cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a confirmed diagnosis of either:

               -  Acute lymphoblastic leukemia

               -  Lymphoblastic lymphoma with detectable abnormal blasts in the bone marrow

          -  In the opinion of the treating investigator, patients must be an unsuitable candidate
             for a pediatric-inspired regimen, reasons for which may include (but not be limited
             to) older age (i.e., >= 40 years), practical/logistical barriers to or toxicity
             concerns from administration of a pediatric-inspired regimen, or Ph+ disease

          -  Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless
             attributable to Gilbert's disease or other causes of inherited indirect
             hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)

          -  Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 5.0 x institutional ULN; (Note: patients with liver test abnormalities attributable
             to hepatic involvement by ALL will be permitted if the total bilirubin is =< 5.0 x ULN
             and ALT/AST are =< 8.0 x ULN)

          -  Creatinine =< 2.0 mg/dL; however, patients with a creatinine > 2.0 mg/dL but with a
             calculated creatinine clearance of > 30 ml/min, as measured by the Modification of
             Diet in Renal Disease (MDRD) equation, will be eligible

          -  As patients with ALL frequently have cytopenias, no hematologic parameters will be
             required for enrollment or to receive the first cycle of treatment; however, adequate
             recovery of blood counts will be required to receive subsequent cycles)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; (performance
             status of 3 will be allowed if poor performance status is thought to be directly
             secondary to ALL)

          -  Must agree to the use of effective contraception while on study treatment, unless they
             are highly unlikely to conceive (defined as [1] surgically sterilized, or [2]
             postmenopausal [i.e., a woman who is > 50 years old or who has not had menses for >= 1
             year], or [3] not heterosexually active for the duration of the study)

          -  Ability to give informed consent and comply with the protocol

          -  Anticipated survival of at least 3 months, independent of ALL

        Exclusion Criteria:

          -  Patients with Burkitt lymphoma/leukemia

          -  Patients must not have received any prior systemic therapy for ALL, except for the
             acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids,
             cytarabine, etc.)

          -  Patients with isolated extramedullary disease or with known parenchymal central
             nervous system (CNS) disease

          -  Known hypersensitivity or intolerance to any of the agents under investigation

          -  Other medical or psychiatric conditions that in the opinion of the investigator would
             preclude safe participation in the protocol

          -  May not be pregnant or nursing