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Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00002756
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.

PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Intensification in Infant ALL: A Children's Oncology Group Study
Study Start Date : June 1996
Actual Primary Completion Date : September 2007
Actual Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemo (Reduced Induction) No BMT (Open February 2004) Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of intensification
  2. Event-free survival
  3. Comparison of event-free survival rates in infants with and without leukemic blasts translocations

Secondary Outcome Measures :
  1. Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome
  2. Clinical prognostic features associated with outcome
  3. Correlation of biologic characteristics of leukemia cells at diagnosis with outcome
  4. Patterns of gene expression

Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

    • No infants less than 36 weeks' gestation
    • CNS or testicular disease permitted
  • No B-cell ALL or acute myeloid leukemia

  • Previously untreated except for the following:

    • Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
  • Concurrent registration on protocol POG-9900 (ALL classification study) required
  • Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study

PATIENT CHARACTERISTICS:

Age:

  • Under 1 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No uncontrolled infection
  • Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent chronic steroid treatment

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer therapy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00002756


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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:
Robinson BW, Devidas M, Carroll AJ, et al.: Specific MLL partner genes in infant acute lymphoblastic leukemia (ALL) associated with outcome are linked to age and white blood cell count (WBC) at diagnosis: A report on the Children's Oncology Group (COG) P9407 trial. [Abstract] Blood 114 (22): A-907, 2009.

Other Publications:

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002756     History of Changes
Other Study ID Numbers: P9407
COG-P9407 ( Other Identifier: Children's Oncology Group )
POG-9407 ( Other Identifier: Pediatric Oncology Group )
CDR0000064693 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
acute undifferentiated leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Cytarabine
6-Mercaptopurine
Prednisone
Etoposide
 Vincristine
Daunorubicin
Asparaginase
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action