Treatment of Older Adults With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Prednisone; Vincristine; Doxorubicin; PEG-asparaginase; Cytarabine; Methotrexate; Imatinib; Clofarabine; 6 Mercaptopurine
Intervention description: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.; Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy; Intravenously during Induction, CNS, and Consolidation 2 therapy; Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy; Intrathecally during Induction and CNS therapy; Intrathecally during Induction, CNS, and Continuation Therapy; Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy; Intravenously during Consolidation 1 Therapy; Orally during CNS, Consolidation 2 and Continuation Therapy
Intervention MeSH terms: Cytarabine; Prednisone; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Mercaptopurine; Clofarabine; Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 51 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ALL

Summary:

      The purpose of this study is to determine the safety and effectiveness of a multi-drug
      regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine,
      and methotrexate) which is considered standard treatment for children and young adults with
      acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to
      treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment
      regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy
      treatment regimens for children with ALL and has been shown to decrease the number of
      leukemia cells. Participants with leukemia that has an abnormal chromosome, called the
      Philadelphia chromosome, will also be given imatinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any
             of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or
             t(2;8).

          -  Patients with mature B-cell ALL will be removed from the protocol as soon as the
             diagnosis is made and should be treated on a B-cell leukemia protocol.

          -  Patients with lymphoblastic lymphoma are also eligible

          -  No prior anti-leukemic therapy except <1 week of steroids, and/or emergent radiation
             therapy to the mediastinum, or hydroxyurea or emergent leukopheresis. Longer steroid
             use for diseases other than leukemia is permitted.

          -  Age 51-75 years

          -  Ejection fraction > 45%

          -  Creatinine < 2.0 mg/dl

          -  Total bilirubin < 3.0 mg/dl

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2

          -  Non-pregnant and non lactating

        Exclusion Criteria:

          -  Known HIV positive

          -  Comorbid medical condition, in the investigator's opinion, would make participation in
             this trial and adherence to the protocol guidelines difficult

          -  Active psychiatric or mental illness making informed consent or careful clinical
             follow-up unlikely