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


Phase 2
N/A
1 Year
Not Enrolling
Both
Leukemia

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed acute lymphoblastic leukemia (ALL) in
infants under 12 months of age at diagnosis Adequate bone marrow and/or peripheral blood
specimens with blasts available No prior treatment for ALL except emergency therapy for
the following: Blast cell crisis Superior vena cava syndrome Renal failure due to leukemic
infiltration of the kidneys

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patricia A. Dinndorf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064841

NCT ID:

NCT00002785

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Children's Mercy Hospital - Kansas CityKansas City, Missouri  64108