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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dutch Childhood Oncology Group
ClinicalTrials.gov Identifier:
NCT00015873
First received: May 6, 2001
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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
Study First Received: May 6, 2001
Last Updated: February 14, 2014
Health Authority: United States: Federal Government
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Dutch Childhood Oncology Group:
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
Asparaginase
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014