Treatment of Older Adults With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      -  This research study has stages of treatment as follows: 1) Induction 2) Consolidation 1
           3) Stem cell of Bone Marrow Transplant (if the participant is eligible). If the
           participant does not have a transplant: 4) CNS Therapy 5) Consolidation 2 6)
           Continuation Therapy.

        -  During all phases of study treatment, participants will have additional tests and
           procedures to monitor their health and for research purposes. These tests will include:
           physical exams, blood tests, bone marrow aspirate/biopsy and EKGs (electrocardiogram)
           and/or ECHOs (echo-cardiogram).

        -  INDUCTION STAGE: This stage lasts for about one month. The study drugs and the way they
           are administered are as follows: Prednisone orally on days 1-21 for participants less
           than 60 and days 1-7 for participants 60 or greater; Vincristine intravenously on days
           1, 8, 15 and 22; Doxorubicin intravenously on days 1 and 2; PEG-Asparaginase
           intravenously on days 7 and 21; Cytarabine intrathecally on day 1; Methotrexate
           intrathecally on day 29; Imatinib orally on days 14-29 if participant has the
           Philadelphia Chromosome.

        -  After induction, if there is evidence of ALL in the spinal fluid, participants may need
           to receive more intrathecal therapy.

        -  CONSOLIDATION 1 Therapy: This stage will last about one month. Participants will receive
           Consolidation 1 Therapy, regardless of whether or not their ALL is in full remission
           after Induction. The study drugs and the way they are administered are as follows:
           Prednisone orally days 1-5; Clofarabine intravenously days 1-5; PEG-Asparaginase
           intravenously days 1 and 15; Imatinib continues orally for participants with the
           Philadelphia Chromosome.

        -  After the participants blood counts return to normal, their bone marrow will be tested.
           If the bone marrow shows remission, participants will proceed to the next stage of the
           study. If the bone marrow does not show remission, the participants will no longer
           continue on this study.

        -  STEM CELL or BONE MARROW TRANSPLANTATION: The next stage is stem cell or bone marrow
           transplantation if the participant is eligible. If the participant receives a stem cell
           transplant, they will receive additional chemotherapy (separate from the study drugs)
           followed by an infusion of stem cells. If the participant receives a bone marrow
           transplant, they will have a bone marrow aspirate and biopsy 3 months after the
           transplant and 12 months from the start fo the induction to monitor the status of the
           ALL. If the participant receives a bone marrow or stem cell transplant, they will
           continue to be a part of the study, but will not proceed with CNS Therapy, Consolidation
           2 Therapy, and Continuation Therapy.

        -  CENTRAL NERVOUS SYSTEM (CNS) THERAPY: CNS therapy will begin between 2 and 6 weeks
           following the end of Consolidation 1. This stage will last about one month. The study
           drugs and the way they are administered are as follows: vincristine intravenously on day
           1; doxorubicin intravenously on day 1; 6 mercaptopurine orally on days 1-14; prednisone
           orally on days 1-5; PEG-asparaginase intravenously on days 1 and 15;
           methotrexate/cytarabine/prednisone intrathecally weekly for 3 weeks; imatinib orally
           continues daily if the participant has the Philadelphia Chromosome.

        -  Radiation therapy will also be given during this stage of the participant is under 60
           years old. The purpose of radiation therapy is to prevent ALL from coming back in the
           brain. Radiation will be given in 8 treatments, given once a day, and will be scheduled
           with other study treatment.

        -  CONSOLIDATION 2 THERAPY: This stage begins as soon as CNS Therapy ends and lasts about 8
           months. Participants will receive repeated cycles of the study drug treatment about
           every 4 weeks. The study drugs and the way they are administered are as follows:
           vincristine intravenously on day 1; doxorubicin intravenously on day 1; 6 mercaptopurine
           orally on days 1-14; prednisone orally days 1-5; PEG-asparaginase orally on days 1 and
           15 (first cycle only); imatinib orally continues daily if the participant has
           Philadelphia chromosome.

        -  CONTINUATION THERAPY: This stage begins at the end of Consolidation 2 Therapy. The goal
           of this stage is to get rid of all of the ALL in the body. Participants will receive
           repeated cycles of the study drug treatment every 4 weeks. It will last until the
           participant has been in remission for 2 years. The study drugs and the way they are
           administered are as follows: vincristine intravenously on day 1; mercaptopurine orally
           on days 1-14; prednisone orally on days 1-5; methotrexate intravenously on day 15;
           imatinib orally continues daily if the participant has Philadelphia chromosome.
    

Intervention name(s): Prednisone; Vincristine; Doxorubicin; PEG-asparaginase; Cytarabine; Methotrexate; Imatinib; Clofarabine; 6 Mercaptopurine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL