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Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00866307
First received: March 19, 2009
Last updated: July 19, 2012
Last verified: March 2011
History of Changes
  Purpose

RATIONALE: Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects of giving pegaspargase together with combination chemotherapy and to see how well it works in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia.


Condition Intervention
Leukemia
 Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: prophylactic cranial irradiation

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility and safety of intensified pegaspargase therapy [ Designated as safety issue: Yes ]

Estimated Enrollment: 165
Study Start Date: February 2009
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed high-risk B-precursor acute lymphoblastic leukemia as defined by 1 of the following criteria:

    • WBC ≥ 50,000/μL (for patients 1-10 years of age)
    • Any WBC (for patients 10-30 years of age)
    • Any WBC AND have received prior steroid therapy
    • Any WBC with biopsy proven testicular leukemia disease
  • Enrolled on clinical trial COG-AALL03B1 or the successor classification study

  • No Philadelphia chromosome-positive (Ph+) disease, as defined by the following:

    • BCR-ABL fusion transcript determined by FISH or RT-PCR
    • t(9;22)(q34;q11) determined by cytogenetics

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No Down syndrome

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent intensity-modulated radiotherapy

  • No prior cytotoxic chemotherapy except steroids and intrathecal cytarabine

    • Systemic chemotherapy must begin within 72 hours of intrathecal cytarabine
    • Inhalational steroids not considered as pretreatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866307

  Show 24 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Zoann E. Dreyer, MD Texas Children's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00866307     History of Changes
Other Study ID Numbers: CDR0000636174, COG-AALL08P1
Study First Received: March 19, 2009
Last Updated: July 19, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
B-cell adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Pegaspargase
 Daunorubicin
Dexamethasone
Doxorubicin
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013