Trial Information

TREATMENT OF NEWLY DIAGNOSED ACUTE LYMPHOBLASTIC LEUKEMIA IN INFANTS LESS THAN 1 YEAR OF AGE

OBJECTIVES: I. Assess the feasibility and outcome of intensified induction/consolidation
followed by intensified re-induction/re-intensification in infants less than 1 year of age
with newly diagnosed acute lymphocytic leukemia (ALL). II. Evaluate the feasibility and
outcome of bone marrow transplantation using family or unrelated donors in infants with the
11q23 abnormality. III. Evaluate neuropsychologic outcome upon completion of protocol
therapy in patients who have reached the ages of 3 and 7 years, with special attention to
the outcome in infants who received total-body irradiation. IV. Study the biology of infant
ALL in samples of leukemic blood and bone marrow. V. Study the possible associations among
patient- and disease-specific factors and family sociodemographic characteristics that
mediate treatment outcome.

OUTLINE: Upon completion of Induction/Intensification and Re-Induction therapy, patients
with the 11q23 abnormality and with a matched or one-antigen mismatched related or unrelated
donor proceed immediately to Transplantation; all others proceed to Re-Intensification,
Consolidation, Intensified Maintenance, and Routine Maintenance. The following acronyms are
used: AlBM Allogeneic Bone Marrow ARA-C Cytarabine, NSC-63878 ASP Asparaginase, NSC-109229
CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 CYSP Cyclosporine,
NSC-290193 DM Dexamethasone, NSC-34521 DNR Daunorubicin, NSC-82151 G-CSF Granulocyte-Colony
Stimulating Factor (Amgen), NSC-614629 HC Hydrocortisone, NSC-10483 MePRDL
Methylprednisolone, NSC-19987 Mesna Mercaptoethane sulfonate, NSC-113891 MP Mercaptopurine,
NSC-755 MTX Methotrexate, NSC-740 PEG-ASP Pegaspargase, NSC-644954 PRED Prednisone,
NSC-10023 TBI Total-Body Irradiation TIT Triple Intrathecal Therapy (IT ARA-C/IT HC/IT MTX)
VCR Vincristine, NSC-67574 VH Very High Dose VP-16 Etoposide, NSC-141540
INDUCTION/INTENSIFICATION: 5-Drug Combination Systemic Chemotherapy followed by 3-Drug
Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy.
DM/VCR/DNR/CTX/Mesna/ASP; followed by MTX/CF/VP-16/CTX/Mesna; plus TIT. RE-INDUCTION: 5-Drug
Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy.
DNR/VCR/CTX/Mesna/ASP/DM; plus TIT. RE-INTENSIFICATION: 2-Drug Combination Systemic
Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination
Systemic Chemotherapy. VCR/VH MTX/CF; plus IT ARA-C; followed by VP-16/CTX/Mesna.
CONSOLIDATION: 2-Drug Combination Systemic Chemotherapy followed by 2-Drug Combination
Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy. ARA-C/ASP; followed by VH
MTX/CF/VCR; plus IT ARA-C. INTENSIFIED MAINTENANCE: 4-Drug Combination Systemic Chemotherapy
plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination Systemic
Chemotherapy. DM/VCR/MTX/MP; plus IT ARA-C followed by VP-16/CTX/Mesna. ROUTINE MAINTENANCE:
4-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy.
VCR/MTX/MP/PRED; plus IT MTX. TRANSPLANTATION: 2-Drug Combination Myeloablative Chemotherapy
followed by Radiotherapy followed by Hematopoietic Rescue plus GVHD Prophylaxis. ARA-C/CTX;
followed by TBI using a linear accelerator or Co60 equipment; followed by AlBM; plus MePRDL;
CYSP.

PROJECTED ACCRUAL: 100 patients per year will be entered over approximately 3 years.