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Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: Prince of Wales Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00707083
  Purpose

RATIONALE: 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. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.


Condition Intervention
Leukemia
Drug: dexamethasone
Drug: mercaptopurine
Drug: methotrexate
Drug: vincristine sulfate

MedlinePlus related topics: Cancer Leukemia, Childhood
Drug Information available for: Mercaptopurine 6-Mercaptopurine Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Vincristine sulfate Vincristine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
Official Title: A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Bone marrow suppression [ Designated as safety issue: Yes ]
  • Liver toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Infection rate [ Designated as safety issue: Yes ]
  • Hospitalization rate [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: May 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard- or Intermediate-Risk Maintenance Arm I: Active Comparator
Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
Drug: dexamethasone
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given orally
Drug: vincristine sulfate
Given IV
Standard- or Intermediate-Risk Maintenance Arm II: Experimental
Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
Drug: dexamethasone
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given orally
Drug: vincristine sulfate
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:

    • Standard-risk disease:

      • Age 1 to 9 years
      • WBC < 50/mm^3 OR TEL/AML1-positive disease
      • Good response to prior prednisone (day 8 peripheral blood blast < 1,000/mm^3)
      • None of the following subtypes:

        • T-cell
        • t(9;22)
        • t(4;11)
        • t(1;19)
        • Molecular
      • Bone marrow (BM) M1 or M2 on day 15, BM remission (< 5% blast) on day 33
    • Intermediate-risk disease:

      • Good response to prior prednisone
      • BM M1/M2 on day 15
      • Meets 1 of the following criteria:

        • At least 10 years old
        • WBC > 50/mm^3
        • Under 1 year old without MLL gene rearrangement
        • T-cell OR t(1;19) OR E2A/PBX1
        • Standard-risk patient with BM M3 on day 15
        • If minimal residual disease (MRD) available, day 33 MRD < 10^-2
    • High-risk disease, meeting 1 of the following criteria:

      • Poor response to prior prednisone
      • t(9;22), BCR/ABL, t(4;11), OR MLL/AF4
      • Intermediate-risk patient with BM M3 on day 15
      • BM M2/M3 on day 33
      • If MRD available, flow cytometry/PCR > 10% on days 15 OR MRD > 10^-2 on day 33 OR MRD (before mM or M phase) > 10^-3 on day 84

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707083

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Chi-Kong Li, MD     852-2632-1019        
Queen Mary Hospital - Hong Kong Recruiting
Hong Kong, China
Contact: Contact Person     852-2855-3453        
Sponsors and Collaborators
Prince of Wales Hospital
Investigators
Principal Investigator: Chi-Kong Li, MD Prince of Wales Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000595184, POWH-CRE-2008.077-T
Study First Received: June 27, 2008
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00707083  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
B-cell childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia

Study placed in the following topic categories:
Dexamethasone
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Vincristine
6-Mercaptopurine
Recurrence
Folic Acid
Leukemia
Lymphatic Diseases
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on January 16, 2009