A Study in Adults With Untreated Acute Lymphoblastic Leukemia

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Brief Title

A Study in Adults With Untreated Acute Lymphoblastic Leukemia

Official Title

A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol

Brief Summary

      The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in
      adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
    

Detailed Description

      This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3)
      intensification, and 4) continuation.

      The induction phase lasts one month and eight drugs are used during this phase of treatment.
      The drugs are administered as follows:

        -  Prednisone; on days 1-28:

        -  Vincristine; on days 1, 8, 15, and 22:

        -  Doxorubicin; on days 1 and 2:

        -  Methotrexate; on day 3;

        -  Leucovorin; 36 hours after methotrexate:

        -  Asparaginase; on day 5:

        -  Intra-thecal Cytarabine; on days 1, 15, and 29:

        -  Intra-thecal Methotrexate/Hydrocortisone; on days 15 and 29

      A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy.
      If on day 29, the patients' bone marrow and peripheral blood counts are not in complete
      remission, then the patient may receive vincristine on days 29, 36 and 43. Bone marrow biopsy
      will be repeated weekly until complete remission is documented. If the patient does not
      achieve complete remission by day 49, they will be removed from the study.

      Central nervous system (CNS) therapy begins immediately after the end of the induction
      therapy. This phase of treatment should last 3 weeks. Treatment includes a series of spinal
      taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a
      two week period. Anti-leukemia drugs will also be given orally. The drugs given are as
      follows: Vincristine; on day 1: Doxorubicin; on day 1: 6-mercaptopurine (6-MP); on days 1-14:
      Intra-thecal Methotrexate/Cytarabine; 4 times over 2 weeks.

      Radiation therapy (RT) will be delivered in 10 daily treatments during the CNS phase of
      therapy.

      The intensification phase begins as soon as the CNS phase ends and lasts approximately 30
      weeks. It consists of cycles of chemotherapy repeated every 3 weeks, along with asparaginase
      administered weekly. The drugs given are as follows: Vincristine; day 1: Dexamethasone; days
      1-5: 6-MP; days 1-14: Doxorubicin; day 1: Asparaginase; weekly: Methotrexate; weekly:
      Intra-thecal Hydrocortisone/Methotrexate/cytarabine; every 18 weeks.

      The continuation phase of treatment begins after the intensification phase. It consists of
      cycles of chemotherapy repeated every three weeks and will last until the patient is in
      remission for two years. The drugs given are: Vincristine; day 1 : Prednisone or
      Dexamethasone; days 1-5: 6-MP; days 1-14: Methotrexate; weekly: Intra-thecal
      Methotrexate/Cytarabine/Hydrocortisone: every 18 weeks.

      During this study, blood tests will be performed at the start of therapy, at day 29 post
      induction and at the time of each intra-thecal therapy (every 18 weeks).

      Bone marrow biopsy/aspirate will be done days 15 and 29 of induction, then every 6 months
      until completion.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

To determine the feasibility, safety and efficacy of the high-risk pediatric treatment regimen in adult patients between the ages of 18 and 50 years

Secondary Outcome

 To determine the safety and optimal dosing of L-asparaginase during the intensification period

Condition

Acute Lymphoblastic Leukemia

Intervention

prednisone

Study Arms / Comparison Groups

 Only Arm for this study
Description:  Only Arm for this study

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

100

Start Date

June 2002

Completion Date

January 2020

Primary Completion Date

July 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have pathologically documented acute lymphoblastic leukemia, excluding
             mature B-cell ALL.

          -  No prior therapy for leukemia with the following exceptions:

               -  up to one week of steroids;

               -  emergent leukapheresis;

               -  emergency treatment for hyperleukocytosis with hydroxyurea;

               -  cranial RT for CNS leukostasis (one dose only);

               -  emergent radiation therapy to the mediastinum.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

          -  Between the ages of 18 to 50 years.

        Exclusion Criteria:

          -  Uncontrolled active infection.

          -  Pregnancy or nursing mothers.

          -  Prior history of pancreatitis.

          -  Prior history of a cerebrovascular accident or hemorrhage.

          -  Evidence of infection with the human immunodeficiency virus.

          -  Active psychiatric or mental illness making informed consent or careful clinical
             follow-up unlikely.

          -  The treating physician should consider all relevant medical and other considerations
             when deciding whether this protocol is appropriate for a particular patient.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Daniel J. DeAngelo, MD, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00136435

Organization ID

01-175


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Brigham and Women's Hospital

Study Sponsor

Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

June 2019