A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 2,231
- Locations
- 2
- Primary Endpoint
- Bone marrow suppression and liver toxicity
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- Compare the incidence of marrow suppression with 2 methods of maintenance treatment in children with acute lymphoblastic leukemia.
- Compare the incidence of liver toxicity with 2 methods of maintenance treatment in these patients.
Secondary
- Determine any difference in infection rates and related hospitalizations in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: dexamethasone (Drug)
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.
Intervention: mercaptopurine (Drug)
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.
Intervention: methotrexate (Drug)
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.
Intervention: vincristine sulfate (Drug)
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.
Intervention: dexamethasone (Drug)
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.
Intervention: mercaptopurine (Drug)
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.
Intervention: methotrexate (Drug)
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.
Intervention: vincristine sulfate (Drug)
Outcomes
Primary Outcomes
Bone marrow suppression and liver toxicity
Time Frame: 24 or 30 months of chemotherapy
compare marrow suppression in the two arms of maintenance treatment
Secondary Outcomes
- overall and event-free survival(3 years after stop treatment)
- Hospitalization rate during maintenance treatment(24 or 30 months after chemotherapy)
Investigators
Chi Kong Li
Dr.
Prince of Wales Hospital, Shatin, Hong Kong