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Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00015873
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dutch Childhood Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective for treating infants with acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: asparaginase Drug: cytarabine Drug: mercaptopurine Drug: methotrexate Drug: prednisolone Drug: vincristine sulfate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia
Study Start Date : May 1999
Actual Primary Completion Date : February 2006
Actual Study Completion Date : December 2009


Arm Intervention/treatment
No Intervention: A no VIMARAM
No VIMARAM preceding maintenance treatment
Experimental: B - VIMARAM
VCR i.v. 1.5 mg/m2/d - 4 days 6-MP p.o. 25 mg/m2/d - 15 days HD-MTX p.i.(24hr) 5 g/m2 - 2 days MTX + pred I.T. (age adapted) - 2 days HD-Ara-C p.i (3hr) 3 g/m2/12 hrs -8 days L-ASP p.i. (1hr) 5.000 U/m2 - 2 days
Drug: asparaginase
Drug: cytarabine
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisolone
Drug: vincristine sulfate



Primary Outcome Measures :
  1. Event-free survival at 3-4 years after diagnosis [ Time Frame: 4 years after diagnosis ]
    Event-free survival



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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:

  • Diagnosis of acute lymphoblastic leukemia (ALL)

    • Newly diagnosed
    • Morphological verification by cytochemistry and immunophenotyping
  • CNS or testicular leukemia at diagnosis allowed
  • Trisomy 21 allowed

PATIENT CHARACTERISTICS:

Age:

  • 365 days or less

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for leukemia

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • Prior inhaled steroids allowed

Radiotherapy:

  • No prior radiotherapy for leukemia

Surgery:

  • Not specified

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): NCT00015873


  Show 33 Study Locations
Sponsors and Collaborators
Dutch Childhood Oncology Group
Investigators
Study Chair: Rob Pieters, MD, MSC, PhD Erasmus MC - Sophia Children's Hospital

Publications of Results:
Pieters R, Schrappe M, de Lorenzo P, et al.: Outcome of infants less than one year of age with acute lymphoblastic leukemia treated with the Interfant-99 protocol. [Abstract] Blood 108 (11): A-145, 2006.

Responsible Party: Dutch Childhood Oncology Group
ClinicalTrials.gov Identifier: NCT00015873     History of Changes
Other Study ID Numbers: CDR0000068529
ICU-INTERFANT99
UKCCSG-LK-1999-05
EU-20063
EU-20588
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by Dutch Childhood Oncology Group:
untreated childhood acute lymphoblastic 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
Methotrexate
Cytarabine
6-Mercaptopurine
Vincristine
Prednisolone
Asparaginase
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors