Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
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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. |
- 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
- 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 |
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| 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 | |
| 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 May 23, 2013