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

This study has been completed.
Information provided by (Responsible Party):
Dutch Childhood Oncology Group Identifier:
First received: May 6, 2001
Last updated: February 14, 2014
Last verified: February 2014

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 Intervention Phase
Leukemia Drug: asparaginase Drug: cytarabine Drug: mercaptopurine Drug: methotrexate Drug: prednisolone Drug: vincristine sulfate Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dutch Childhood Oncology Group:

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

Estimated Enrollment: 350
Study Start Date: May 1999
Study Completion Date: December 2009
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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


  • Diagnosis of acute lymphoblastic leukemia (ALL)

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



  • 365 days or less

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • No prior chemotherapy for leukemia

Endocrine therapy:

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


  • No prior radiotherapy for leukemia


  • Not specified
  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 identifier: NCT00015873

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

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 Identifier: NCT00015873     History of Changes
Other Study ID Numbers: CDR0000068529
Study First Received: May 6, 2001
Last Updated: February 14, 2014

Keywords provided by Dutch Childhood Oncology Group:
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017