Treatment of Acute Lymphoblastic Leukemia in Children

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Brief Title

Treatment of Acute Lymphoblastic Leukemia in Children

Official Title

Treatment of Acute Lymphoblastic Leukemia in Children

Brief Summary

      The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The
      therapy in this study is based upon treatment information learned from prior clinical
      research programs as well as from laboratory research.
    

Detailed Description

      -  Children with acute lymphoblastic leukemia are treated somewhat differently depending on
           the relative risk of the leukemia recurring. Patients will be separated into "Standard
           Risk" and "High Risk".

        -  The treatment program for both groups is separated into 4 phases. The phases of
           treatment are induction, central nervous system (CNS) therapy, intensification and
           continuation.

        -  The induction phase of therapy lasts for about one month and its purpose is to kill all
           detectable leukemia cells. Patients in both groups will receive the following
           medication: prednisone, vincristine, doxorubicin, methotrexate, leucovorin,
           asparaginase, cytarabine (ARA-C), and hydrocortisone. Patients in the "Hight Risk" group
           will also receive dexrazoxane.

        -  Patients whose leukemia is found to have a specific genetic abnormality involving a gene
           on chromosome 11 (known as MLL gene) will have a MLL intensification phase which begins
           after complete remission and lasts about 1 month. The drugs involved in MLL
           intensification are: vincristine, methotrexate, leucovorin, hydrocortisone, cytarabine
           and L-asparaginase.

        -  CNS therapy begins immediately after the end of induction therapy, after remission is
           documented. This phase of treatment should last 3 weeks and includes a series of spinal
           taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed
           over a two-week period. Both groups will receive vincristine, 6-mercaptopurine and
           methotrexate/cytarabine/hydrocortisone. Patients in the "High Risk" group will also
           receive doxorubicin with dexrazoxane.

        -  Radiation therapy will also be delivered to patients in the "High Risk" group during the
           CNS therapy phase. Radiation will be given in 8 daily treatments. The total dose of
           radiation used during this study is lower than what has been used in the past to help
           reduce side effects without increasing the risk of relapse.

        -  The intensification phase begins after the CNS therapy ends and lasts for 30 weeks. This
           phase is intended to further reduce the number of leukemia cells in the body and
           consists of cycles of chemotherapy repeated every three weeks with weekly shots of
           asparaginase. The drugs administered to both groups during this phase are: prednisone or
           dexamethasone, vincristine,6-mercaptopurine, methotrexate, E. coli asparaginase and
           cytarabine. Patients in the "High Risk" group will also receive doxorubicin and
           dexrazoxane.

        -  The continuation phase begins after the completion of the intensification phase and the
           goal is to eradicate all leukemia from the body. It consists of cycles of chemotherapy
           repeated every 3 weeks and is continued until the patient has been in remission for 2
           years. The drugs administered during this phase are vincristine, prednisone or
           dexamethasone, 6-mercaptopurine, methotrexate and cytarabine.

        -  During this trial there are two randomizations, each is between the "standard" treatment
           and the "investigational" treatment. One randomization involves the drug E. coli
           L-asparaginase and two ways of dosing this drug. One way is to give the same standard
           dose of the drug that has been administered for years. The other way is to start with a
           lower dose and measure the amount of the drug in the blood every 3 weeks adjusting the
           dose as necessary. The goal of doing this is to maintain adequate drug levels with lower
           doses in the hope the it may reduce some side effects of the drug.

        -  The second randomization involves the drugs prednisone and dexamethasone. Both drugs
           have been used in the past to help treat ALL but it is not known if there is a
           difference between the two drugs, especially in terms of side effects. Patients will be
           randomized to either receive dexamethasone or prednisone.

        -  Throughout the study blood tests, urine tests, spinal taps, and bone marrow tests will
           be performed to monitor the disease status, side effects from medications and other
           complications from therapy.

        -  Quality of life questionnaires will also be performed by the patient (if older than 8),
           parent and patient's clinician.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

To optimize dosing of E. coli L-asparaginase during the intensification period

Secondary Outcome

 To compare randomized treatment groups using health-related, quality-of-life analysis

Condition

Acute Lymphoblastic Leukemia

Intervention

prednisone

Study Arms / Comparison Groups

 Individualized ASP dose
Description:  

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

498

Start Date

September 2000

Completion Date

May 2011

Primary Completion Date

December 2004

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)

          -  Age > 12 months but less than 18 years

        Exclusion Criteria:

          -  Prior therapy except, 1 week of steroids, or emergent radiation therapy to the
             mediastinum

          -  Known HIV positive
      

Gender

All

Ages

1 Year - 18 Years

Accepts Healthy Volunteers

No

Contacts

Lewis Silverman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00165178

Organization ID

00-001


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Boston Children’s Hospital

Study Sponsor

Lewis Silverman, MD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

April 2013