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Treatment of Childhood Acute Lymphoblastic Leukemia

20 december 2007 uppdaterad av: Dana-Farber Cancer Institute
The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia therapy, to attain long-term control of the disease and to hopefully eradicate it.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

  • Children with acute lymphoblastic leukemia (ALL) are treated somewhat differently depending upon on the relative risk of the leukemia recurring. For this study they are classified into "Standard Risk", "High Risk" and "Infant/High Risk".
  • The treatment for patients in the "Standard Risk" and "High Risk" groups consists of three phases of therapy: induction treatment; prevention of brain and spinal cord leukemia (CNS treatment); and intensification/continuation chemotherapy.
  • The treatment for patients in the "Infant/High Risk" group consists of four phases of therapy: induction treatment; infant intensification therapy; intensification/continuation chemotherapy; and CNS treatment.
  • The induction treatment consists of a combination of chemotherapy drugs whose purpose is to kill all detectable leukemia cells. This process usually requires a least one month and includes six anti-leukemia drugs. These drugs are: vincristine, doxorubicin, methotrexate, cytosine arabinoside, asparaginase and steroids (methylprednisolone or prednisone).
  • After the induction phase, "Infant/High Risk" patients will receive a highly intensive month of treatment (infant intensification) . Drugs used during this month include high-dose methotrexate, asparaginase, 6-mercaptopurine and high dose cytosine arabinoside (ARA-C).
  • CNS treatment begins during induction therapy but is intensified during the second and third month after diagnosis. Treatment for all patients will include a series of spinal taps with the instillation of anti-leukemia drugs, including cytosine arabinoside and methotrexate and with or without hydrocortisone (depending upon randomization).
  • All high risk patients (those in both "High Risk" and "Infant/High Risk") as well as some standard risk patients will receive radiation treatment to the brain. Radiation therapy will either be given in either "conventional" treatments (once daily for 10 days), or "hyperfractionated" treatments (twice daily at half doses for 10 days). Total dose of radiation is 1800 cGy.
  • Intensification and continuation therapy, begins 4-5 weeks after diagnosis for "Standard Risk" and "High Risk" groups and 4-5 weeks after infant intensification in "Infant/High Risk" group. This phase of treatment continues until the completion of two years of treatment. Patients in the "Standard Risk" group will receive five anti-leukemia drugs (vincristine, prednisone, methotrexate, asparaginase, and 6-mercaptopurine). Patients in "High Risk" and "Infant/High Risk" will receive six anti-leukemia drugs (vincristine, prednisone, doxorubicin, methotrexate, asparaginase and 6-mercaptopurine).
  • All patients will be able to participate in a randomization comparing two types of asparaginase, E.coli and Erwinia. Patients will be randomized to receive either once weekly E.coli or once-weekly Erwinia during the Intensification phase, each given for a total of 20 weeks.
  • Patients in the "Standard Risk" group are able to participate in an additional randomization. Standard risk patients will be randomized to receive one of two different regimens designed to prevent central nervous system leukemia, either 1)radiation therapy (given twice daily) with chemotherapy in the spinal fluid every 18 weeks, or 2) intensive chemotherapy in the spinal fluid alone without radiation.
  • Patients in the "High Risk" and "Infant/High Risk" groups are able to participate in two randomizations in addition to the asparaginase randomization. The first will be to assess whether the drug dexrazoxane prevents heart damage caused by doxorubicin without affecting risk of relapse. Patients will be randomized to receive either doxorubicin alone or doxorubicin with dexrazoxane during the induction, CNS and intensification phases. The second randomization will compare the relative efficacy and toxicity of different cranial radiation schedules. Patients will be randomized to receive radiation in either once daily or twice daily fractions.
  • Blood and bone marrow samples will be collected to learn more about the biology of leukemia. These samples will also be used to test minimal residual disease levels to learn if these levels help predict risk of relapse.
  • Quality of life questionnaires will also be performed by the parents of patients, by children over eight, and by the child's clinician.

Studietyp

Interventionell

Inskrivning

491

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70121
        • Ochsner Clinic
    • Maine
      • Lewiston, Maine, Förenta staterna, 04240
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Förenta staterna, 02115
        • Children's Hospital Boston
    • New York
      • New York, New York, Förenta staterna, 10029
        • Mt. Sinai Medical Center
      • Rochester, New York, Förenta staterna, 14627
        • University of Rochester
  • Kanada
    • Ontario
      • Hamilton, Ontario, Kanada
        • McMaster University
    • Quebec
      • Montreal, Quebec, Kanada
        • Laval University
      • Montreal, Quebec, Kanada
        • Sainte Justine Hosptial
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Children's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Acute lymphoblastic leukemia, excluding known mature B-cell ALL
  • < 18 years of age
  • Patients who are leukopheresed or exchanged are eligible for study only after completion of the pheresis or exchange transfusion
  • Absence of a t(8,14) (q24; q32), t (8,22), t(2,8)
  • Total bilirubin < 1.4mg/dl

Exclusion Criteria:

  • Known HIV positive
  • Prior steroid therapy within 30 days of diagnosis
  • Septic shock
  • Ongoing intracranial hemorrhage
  • Clinical evidence of CNS or lung leukostasis

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
-To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane
-To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.
-To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase
-To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.

Sekundära resultatmått

Resultatmått
-To compare randomized treatment groups using health-related quality of life analyses.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Dana-Farber Cancer Institute

Samarbetspartners

Boston Children's Hospital

Utredare

  • Huvudutredare: Stephen E. Sallan, MD, Dana-Farber Cancer Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 1996

Primärt slutförande (Faktisk)

1 september 2006

Avslutad studie (Faktisk)

1 september 2006

Studieregistreringsdatum

Först inskickad

9 september 2005

Först inskickad som uppfyllde QC-kriterierna

9 september 2005

Första postat (Uppskatta)

14 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 december 2007

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2007

Senast verifierad

1 december 2007

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 95-001

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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