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

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Treatments: 6-Mercaptopurine; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Mercaptopurine; Methotrexate; Vincristine

Criteria

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