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Treatment of Childhood Acute Lymphoblastic Leukemia

This study has been terminated.
(Terminated by IRB for continuing review)
Sponsor:
Collaborator:
Children's Hospital Boston
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165087
First received: September 9, 2005
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: asparaginase (E. Coli)
Drug: asparaginase (Erwina)
Drug: dexrazoxane
Drug: doxorubicin
Procedure: cranial radiation (once daily fractionation)
Procedure: cranial radiation (twice-daily fractionation)
Procedure: Intrathecal chemotherapy without radiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • -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.

Secondary Outcome Measures:
  • -To compare randomized treatment groups using health-related quality of life analyses.

Estimated Enrollment: 491
Study Start Date: January 1996
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165087

Locations
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14627
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Canada, Quebec
Laval University
Montreal, Quebec, Canada
Sainte Justine Hosptial
Montreal, Quebec, Canada
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
Dana-Farber Cancer Institute
Children's Hospital Boston
Investigators
Principal Investigator: Stephen E. Sallan, MD Dana-Farber Cancer Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00165087     History of Changes
Other Study ID Numbers: 95-001
Study First Received: September 9, 2005
Last Updated: December 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
childhood ALL
standard risk
high risk
infant/high risk

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014