Treatment of Older Adults With Acute Lymphoblastic Leukemia

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Brief Title

Treatment of Older Adults With Acute Lymphoblastic Leukemia

Official Title

Treatment of Older Adults With Acute Lymphoblastic Leukemia

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Survival at One Year


Condition

Acute Lymphoblastic Leukemia

Intervention

Prednisone

Study Arms / Comparison Groups

 Experimental
Description:  All patients treated on same arm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

August 2009

Completion Date

April 2016

Primary Completion Date

December 2014

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
      

Gender

All

Ages

51 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Amir Fathi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00973752

Organization ID

08-356


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Dana-Farber Cancer Institute

Study Sponsor

Amir Fathi, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

February 2017