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A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia


Phase 2
N/A
1 Year
Open (Enrolling)
Both
Leukemia

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Trial Information

A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia


OBJECTIVES:

- Determine the feasibility of dexamethasone-based induction chemotherapy followed by
augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without
allogeneic bone marrow transplantation in infants with previously untreated acute
lymphoblastic leukemia.

- Determine the event-free survival of patients treated with this regimen.

- Determine the clinical prognostic features associated with outcome in these patients.

- Compare the biologic characteristics of the leukemia cells with outcome in these
patients.

OUTLINE: This is a multicenter study.

Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14;
daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and
asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also
receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt
CNS disease).

Patients with M1 or M2 marrow after induction therapy receive augmented consolidation
therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29;
cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral
mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50;
pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15.

Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance
#1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32;
methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on
days 2 and 23.

When blood counts recover, patients receive delayed intensification #1 comprising
vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral
dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43;
cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days
29-42; and cytarabine IV or SC on days 30-33 and 37-40.

When blood counts recover, patients receive interim maintenance #2 comprising vincristine as
in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41;
and pegaspargase IM on days 2 and 23.

When blood counts recover, patients receive delayed intensification #2 comprising
vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and
thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and
29.

When blood counts recover, patients receive maintenance therapy comprising methotrexate IT
on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV
on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and
oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses.

Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after
receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in
place of each dose of pegaspargase during delayed intensification #1 and #2.

After augmented consolidation therapy, patients meeting the following criteria may receive
BMT in place of chemotherapy:

- In remission

- Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)}

- Available HLA-A, B, DR genotypic identical relative donor

- No uncontrolled infection

- Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing
allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV
over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to
0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients
receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours
beginning on day -1, switching to oral when possible, and continuing until day 60.
Patients then taper cyclosporine over the next 60-120 days.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months
for 1 year, every 6 months for 1-2 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute
undifferentiated leukemia

- CNS or testicular disease allowed

- No L3 sIg+ ALL or acute myelogenous leukemia

- At least 36 weeks gestation for congenital ALL

PATIENT CHARACTERISTICS:

Age:

- Under 366 days at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar
puncture results known

- No chronic steroid treatment for other disease

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent cytotoxic therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul S. Gaynon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Federal Government

Study ID:

CDR0000068787

NCT ID:

NCT00022126

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • L1 childhood acute lymphoblastic leukemia
  • L2 childhood acute lymphoblastic leukemia
  • acute undifferentiated leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Mount Sinai School of MedicineNew York, New York  10029
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Loma Linda University Medical CenterLoma Linda, California  92354
Deaconess Medical CenterSpokane, Washington  99210-0248
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Madigan Army Medical CenterTacoma, Washington  98431-5048
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
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 Mercy HospitalKansas City, Missouri  64108
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 Healthcare of Atlanta - Scottish RiteAtlanta, Georgia  30342
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Children's Hospital Central CaliforniaMadera, California  93638-8762
Children's Hospital of OaklandOakland, California  94609-1809
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Children's Hospitals and Clinics - MinneapolisMinneapolis, Minnesota  55404
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Children's Hospitals and Clinics - MinnesotaSaint Paul, Minnesota  55102
Methodist Cancer CenterSan Antonio, Texas  78229-3902