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Clinical Trials/NCT00707083
NCT00707083CompletedPhase 3

A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.

Prince of Wales Hospital, Shatin, Hong Kong2 sites in 1 country2,231 target enrollmentStarted: May 1, 2008Last updated:
Conditions
Interventions
Drugs

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

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.

Intervention: dexamethasone (Drug)

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.

Intervention: mercaptopurine (Drug)

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.

Intervention: methotrexate (Drug)

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.

Intervention: vincristine sulfate (Drug)

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.

Intervention: dexamethasone (Drug)

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.

Intervention: mercaptopurine (Drug)

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.

Intervention: methotrexate (Drug)

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.

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

Sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chi Kong Li

Dr.

Prince of Wales Hospital, Shatin, Hong Kong

Study Sites (2)

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