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Trial record 33 of 47 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Pegaspargase"

Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225874
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : February 23, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. 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) may kill more cancer cells.

PURPOSE: This trial is studying biomarkers to classify young patients with acute lymphoblastic leukemia (ALL) and remission induction therapy in young patients with B-precursor ALL.

Condition or disease Intervention/treatment Phase
Leukemia Drug: SC-PEG E. coli L-asparaginase Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3762 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALinC 17, Classification ©), B-precursor Induction Treatment (I)
Study Start Date : December 1999
Actual Primary Completion Date : March 2006

Arm Intervention/treatment
Experimental: Stratum 3
Patients receive oral dexamethasone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; pegaspargase intramuscularly (IM) on day 4, 5, or 6; cytarabine intrathecally (IT) on day 1; and methotrexate IT on day 8 (some patients also receive methotrexate IT on days 15 and 22).
Drug: cytarabine
Given IT

Drug: dexamethasone
Given orally

Drug: methotrexate
Given IT

Drug: pegaspargase
Given IM

Drug: vincristine sulfate
Given IV

Experimental: Stratum 4
Patients receive oral prednisone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; IM SC-PEG E. coli asparaginase on days 2, 5, 8, 12, 15, and 19; daunorubicin hydrochloride IV over 15-20 minutes on days 8, 15, and 22; and methotrexate IT on days 1 and 8 (some patients also receive methotrexate IT on days 15 and 22).
Drug: SC-PEG E. coli L-asparaginase
Given IM

Drug: cytarabine
Given IT

Drug: daunorubicin hydrochloride
Given IV

Drug: methotrexate
Given IT

Drug: prednisone
Given orally

Primary Outcome Measures :
  1. Collection of the clinical and laboratory data necessary for placing patients with acute lymphoblastic leukemia (ALL) onto the proper therapeutic trial (Classification)
  2. Creation of an administrative base to capture classification data for correlative studies in ALL treatment protocols and series of historical protocols (Classification)
  3. Creation of appropriate induction regimens for patients (Induction therapy)
  4. Correlation between event-free survival and measures of minimal-residual disease/early response

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Meets one of the following sets of criteria:

    • Classification study:

      • Newly diagnosed ALL*
      • Must have one of the following:

        • ≥ 25% blasts in bone marrow
        • ≥ 100,000/μl peripheral blood WBC with ≥ 75% blasts, if bone marrow aspiration is omitted for any reason other than medical contraindication
        • ≥ 30,000/μl WBC with ≥ 75% blasts, if bone marrow aspiration is omitted because of medical contraindication
      • Immunophenotype and Wright's stain morphology of blast cells consistent with acute lymphocytic leukemia
      • ≤ 21 years of age at the time of diagnosis
      • No previous registration on 9900
      • Samples must be sent for local institution and COG Reference Laboratory studies NOTE: *It is urged that a bone marrow aspiration be performed for every patient with suspected ALL. However, a marrow is not required for patients with ≥ 100,000/μl peripheral blood WBC and ≥ 75% blasts or for those patients whose clinical condition precludes performing the procedure safely. Patients with a medical contraindication to the procedure must be discussed with one of the study coordinators and must have a peripheral blood WBC of ≥ 30,000/μl with ≥ 75% blasts.
    • Induction therapy study:

      • Patients must have a confirmed diagnosis of B-precursor acute lymphoblastic leukemia
      • Patients must be 1.001 to 21.999 years at diagnosis NOTE: Patients meeting all of the above eligibility criteria are eligible for registration on 9900 whether or not they are to be entered on a COG frontline protocol for treatment of newly diagnosed ALL. Registration on 9900 is required for all legacy POG institution patients in order to be eligible for entry on the following COG ALL studies, which are either currently open or only temporarily closed: P9407, 9904, 9905, 9907, AALL0031 and AALL00P2.


  • See Disease Characteristics


  • Previously untreated, with the following exception:

    • Steroid treatment* in the 48-hour period just prior to study entry will be allowed provided that a physical examination and CBC with differential were performed IMMEDIATELY prior to beginning steroids and results of both are known NOTE: *Patients on chronic steroid treatment for another disease are NOT eligible for a COG New ALL protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225874

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Study Chair: Dale J. Pullen, MD University of Mississippi Cancer Clinic

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Responsible Party: Children's Oncology Group Identifier: NCT01225874    
Other Study ID Numbers: 9900
U10CA030969 ( U.S. NIH Grant/Contract )
COG-9900 ( Other Identifier: Children's Oncology Group )
POG-9900 ( Other Identifier: Pediatric Oncology Group )
CDR0000078618 ( Other Identifier: Clinical )
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action