Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified April 2013 by Prince of Wales Hospital, Shatin, Hong Kong
Sponsor:
Collaborators:
Technology R&D Program, Ministry of Science & Technology, People Republic of China.
Children Cancer Foundation Hong Kong
Information provided by (Responsible Party):
Chi Kong Li, Prince of Wales Hospital, Shatin, Hong Kong
ClinicalTrials.gov Identifier:
NCT00707083
First received: June 27, 2008
Last updated: April 28, 2013
Last verified: April 2013
  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 Phase
Leukemia
Drug: dexamethasone
Drug: mercaptopurine
Drug: methotrexate
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.

Resource links provided by NLM:


Further study details as provided by Prince of Wales Hospital, Shatin, Hong Kong:

Primary Outcome Measures:
  • Bone marrow suppression and liver toxicity [ Time Frame: 24 or 30 months of chemotherapy ] [ Designated as safety issue: Yes ]
    compare marrow suppression in the two arms of maintenance treatment


Secondary Outcome Measures:
  • overall and event-free survival [ Time Frame: 3 years after stop treatment ] [ Designated as safety issue: No ]
  • Hospitalization rate during maintenance treatment [ Time Frame: 24 or 30 months after chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: May 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard- or Intermediate-Risk Maintenance Arm I
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
Experimental: Standard- or Intermediate-Risk Maintenance Arm II
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, Shatin, Hong Kong
Technology R&D Program, Ministry of Science & Technology, People Republic of China.
Children Cancer Foundation Hong Kong
Investigators
Principal Investigator: Chi-Kong Li, MD Prince of Wales Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Chi Kong Li, Dr., Prince of Wales Hospital, Shatin, Hong Kong
ClinicalTrials.gov Identifier: NCT00707083     History of Changes
Other Study ID Numbers: POWH-CRE-2008.077-T, CDR0000595184
Study First Received: June 27, 2008
Last Updated: April 28, 2013
Health Authority: Hong Kong: Department of Health
China: Ministry of Health

Keywords provided by Prince of Wales Hospital, Shatin, Hong Kong:
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

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
Methotrexate
Dexamethasone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on April 22, 2014