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ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study


Phase 3
1 Year
21 Years
Not Enrolling
Both
Leukemia

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Trial Information

ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study


OBJECTIVES:

- Determine whether augmented BFM therapy is superior to ALinc 14/15 therapy in patients
with newly diagnosed high-risk acute lymphoblastic leukemia.

- Determine whether minimal residual disease after induction therapy is predictive of an
inferior prognosis in this patient population.

- Determine the correlation between event-free survival, minimal residual disease, and
early response in this patient population treated with this multiple drug regimen.

OUTLINE: Patients are stratified by CNS or testicular disease (yes vs no).

- Induction therapy (weeks 1-5): Patients receive oral prednisone 3 times daily on days
1-29; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on days 8, 15, 22; and
asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients also
receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 or 3
disease also receive methotrexate IT on days 15 and 22.

Patients with M1 bone marrow proceed to consolidation therapy. Patients achieving M2 bone
marrow on day 29 receive oral prednisone 3 times daily on days 29-42; vincristine IV and
daunorubicin IV over 15 minutes on days 29 and 36; and asparaginase IM on days 29, 32, 36,
and 39. If bone marrow is M3 on day 29 or M2 on day 43, then patient is off study.

- Consolidation therapy (weeks 6-14): Patients receive cyclophosphamide IV over 30
minutes on days 1 and 29; cytarabine subcutaneously (SC) or IV on days 2-5, 9-12,
30-33, and 37-40; oral mercaptopurine daily on days 1-14 and 29-42; vincristine IV on
days 15, 22, 43, and 50; asparaginase IM on days 15, 17, 19, 22, 24, 26, 43, 45, 47,
50, 52, and 54; and methotrexate IT on days 1, 15, 29, and 43.

Patients then proceed to interim maintenance and delayed intensification on weeks 15-46.
Courses repeat every 16 weeks.

- Maintenance I and II (weeks 15-22 and 31-38): Patients receive vincristine IV and
methotrexate IV on days 1, 11, 21, 31, and 41; asparaginase IM on days 2, 12, 22, 32,
and 42; and methotrexate IT on days 1 and 31.

- Delayed Intensification (weeks 23-36 and 39-42): Patients receive vincristine IV on
days 57, 64, and 71; methotrexate IT on day 57; oral dexamethasone 2-3 times daily on
days 57-63 and 71-77; doxorubicin IV over 15 minutes 3 times weekly on days 57, 64, and
71; and asparaginase IM on days 60, 62, 64, 67, 69, and 71.

- Delayed Intensification-Reconsolidation (weeks 27-30 and 43-46): Patients receive oral
thioguanine on days 85-98; methotrexate IT on day 85; cyclophosphamide IV over 30
minutes on day 85; cytarabine IV or SC on days 86-89 and 93-96; asparaginase IM on days
99, 101, 103, 106, 108, and 110; and vincristine IV on days 99 and 106.

- Continuation therapy (weeks 47-130): Patients receive vincristine IV on days 1, 29, and
57; oral dexamethasone twice daily for 5 consecutive days on days 1-5, 29-33, and
57-61; oral mercaptopurine on days 1-84; oral methotrexate on days 8, 15, 22, 29, 36,
43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1.

Patients with CNS 3 disease or who are within 24 months of diagnosis with an initial WBC ≥
100,000/mm^3 undergo whole brain radiotherapy (omit or discontinue mercaptopurine and IT
methotrexate) on day 1. Testicular radiotherapy also begins on day 1.

Patients may receive oral methotrexate on day 1 of each course (if IT methotrexate is not
administered).

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

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 3.1 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell precursor acute lymphoblastic leukemia

- Registered on POG-9900 Classification Study

- Registered within 7 days of documenting complete response after induction on day 29
or, if 2 more weeks of induction are required, no later than day 49

- Classified as high risk:

- No simultaneous trisomy 4 and 10

- No TEL-AML1 gene

- Meets criteria for 1 of the following:

- Any age with WBC > 100,000/mm^3

- CNS and bone marrow evaluations required for those patients with WBC >
100,000/mm^3 who are within 24 months of initial diagnosis

- Age over 12 (boys) or 16 (girls)

- If younger, WBC must be 1 of the following:

- Greater than 80,000/mm^3 (for boys age 8 or girls age 12)

- Greater than 60,000/mm^3 (for boys age 9 or girls age 13)

- Greater than 40,000/mm^3 (for boys age 10 or girls age 14)

- Greater than 20,000/mm^3 (for boys age 11 or girls age 15)

- At least one of the following:

- CNS 3 disease (CSF WBC at least 5/microliter with blasts present)

- Testicular leukemia

- MLL gene rearrangements

PATIENT CHARACTERISTICS:

Age:

- 1 to 21

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

William P. Bowman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cook Children's Medical Center - Fort Worth

Authority:

United States: Federal Government

Study ID:

CDR0000067722

NCT ID:

NCT00005603

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • B-cell childhood acute lymphoblastic 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
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
University of Texas Medical BranchGalveston, Texas  77555-1329
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Saint Jude Midwest AffiliatePeoria, Illinois  61637
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304