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Status:

COMPLETED

Treatment of Acute Lymphoblastic Leukemia in Children

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Drug/Agent Toxicity by Tissue/Organ

Leukemia

Eligibility:

All Genders

1-18 years

Phase:

PHASE3

Brief Summary

RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis,...

Detailed Description

RISK CLASSIFICATION: Patients received were classified into initial risk groups defined as: High Risk (HR) High risk patients had any of the following features: age 10 years and older, a white blood...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • No known mature B-cell ALL, defined by the presence of any of the following:
  • Surface immunoglobulin
  • L3 morphology
  • t(8;14)(q24;q32)
  • t(8;22)
  • t(2;8)
  • T-cell surface markers and t(8;14)(q24;q11) allowed
  • No secondary ALL
  • PATIENT CHARACTERISTICS:
  • No known HIV positivity
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • No prior therapy except steroids of ≤ 1 week in duration and/or emergent radiation therapy to the mediastinum
  • Patients treated with steroids within the past 7 days will not receive steroid prophase during study treatment

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2019

    Estimated Enrollment :

    800 Patients enrolled

    Trial Details

    Trial ID

    NCT00400946

    Start Date

    April 1 2005

    End Date

    June 1 2019

    Last Update

    July 10 2025

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    2

    Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, United States, 10032

    3

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, United States, 14642

    4

    Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, United States, 10461