Status:
COMPLETED
Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
Prince of Wales Hospital, Shatin, Hong Kong
Conditions:
Leukemia
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
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 c...
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 wit...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:
- Standard-risk disease:
- Age 1 to 9 years
- White blood cell (WBC) \< 50/mm\^3 OR t(12;21) or molecular fusion product -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 Mixed Lineage Leukemia (MLL) gene rearrangement
- T-cell OR t(1;19) or molecular fusion product positive.
- 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) or molecular fusion product (BCR/ABL1), t(4;11) or molecular fusion product (MLL/AF4)
- Intermediate-risk patient with BM M3 on day 15
- BM M2/M3 on day 33
- If MRD available, flow cytometry/polymerase chain reaction (PCR) \> 10% on days 15 OR MRD \> 10\^-2 on day 33 OR MRD (before mini-M phase or M phase) \> 10\^-3 on day 84
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
2231 Patients enrolled
Trial Details
Trial ID
NCT00707083
Start Date
May 1 2008
End Date
March 1 2020
Last Update
March 5 2020
Active Locations (2)
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1
Prince of Wales Hospital
Hong Kong, China
2
Queen Mary Hospital - Hong Kong
Hong Kong, China