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ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study

Phase 3
1 Year
21 Years
Not Enrolling

Thank you

Trial Information

ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study


- Determine if multidrug delayed-intensification therapy improves outcome in children
with newly diagnosed standard-risk acute lymphocytic leukemia.

- Compare the efficacy and toxicity of methotrexate administered over 4 hours vs
methotrexate administered over 24 hours 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: This is a randomized, multicenter study.

- Induction (weeks 1-4): Patients receive induction therapy on POG 9900.

- Consolidation (weeks 5-32): Patients are randomized to one of four treatment arms.
Patients with t(1;19) are randomized to either arm III or arm IV.

- Arm I (weeks 5-24): Patients receive IT methotrexate (MTX) on day 1 followed by
MTX IV over 20 minutes followed by MTX continuously over 23.6 hours on weeks 7,
10, 13, 16,19, and 22. At 42 hours after the beginning of the MTX infusion,
patients receive oral leucovorin calcium every 6 hours for a total of 3 doses.
Patients also receive oral mercaptopurine daily beginning on week 5 and continuing
until the completion of consolidation therapy; oral dexamethasone twice daily on
days 1-7 of weeks 8 and 17; and vincristine IV on day 1 of weeks 8, 9, 17, and 18.

- Arm II (weeks 5-24): Patients receive MTX IV over 4 hours on weeks 7, 10, 13, 16,
19, and 22. At 42 hours after the beginning of the MTX infusion, patients receive
oral leucovorin calcium as in arm I. Patients also receive mercaptopurine,
dexamethasone, vincristine, and IT MTX as in arm I.

- Arm III (weeks 5-32): Patients receive MTX IV as in arm I on weeks 7, 10, 13, 24,
27, and 30; leucovorin calcium as in arm I; pegaspargase IM on day 2, 3, OR 4 of
week 16; and oral mercaptopurine daily on weeks 5-13, and from week 24 until the
completion of consolidation therapy. Patients also receive IT MTX as in arm I on
weeks 7, 10, 13, 16, 20, 21, and 30; oral dexamethasone twice daily on weeks 8,
16-18, and 28 for a total of 35 days; vincristine IV on day 1 of weeks 8, 9, 16,
17, 18, 28, and 29; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV
over 30 minutes on day 1 of week 20; cytarabine IV or subcutaneously daily on days
2-5 of weeks 20 and 21; and oral thioguanine daily on weeks 20-21.

- Arm IV (weeks 5-32): Patients receive MTX IV as in arm II on weeks 7, 10, 13, 24,
27, and 30; leucovorin calcium as in arm I; and pegaspargase, mercaptopurine, IT
MTX, dexamethasone, vincristine, daunorubicin, cyclophosphamide, cytarabine, and
thioguanine as in arm III.

- Intensive continuation (weeks 25-80): At weeks 25-72 for arms I and II, and at weeks
33-80 for arms III and IV, patients receive oral MTX every 6 hours for 4 doses on weeks
1, 3, 5, 7, 9, and 11; oral mercaptopurine daily; oral leucovorin calcium every 12
hours for 2 doses beginning 48 hours after the start of MTX; IT MTX and vincristine IV
on day 1 of week 12; and oral dexamethasone twice daily on days 1-7, beginning with the
administration of vincristine. Treatment repeats every 12 weeks for 4 courses.

- Additional continuation (weeks 73-130): At weeks 73-130 for arms I and II, and at weeks
81-130 for arms III and IV, patients receive oral MTX weekly; oral mercaptopurine
daily; vincristine IV on day 1 every 12 weeks; oral dexamethasone as during intensive
continuation therapy; and IT MTX on day 1 every 12 weeks, beginning with the last week
of the first course (in place of oral MTX).

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, every 6 months for 1 year, and then every 6-12 months for 1 year.

PROJECTED ACCRUAL: A total of 1,014 patients will be accrued for this study within 3.22

Inclusion Criteria


- Confirmed diagnosis of newly diagnosed B-precursor acute lymphocytic leukemia

- Standard risk (not low, high, or very high risk)

- Prior registration and treatment on POG 9900 Classification Study



- 1 to 21 at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in outcome in children receiving multidrug delayed-intensification therapy

Outcome Description:

The overall plan is to accrue for 3.1 years or until all accrual goals have been met, whichever occurs first. Since power is determined by event-rates, lower or higher than expected event rates could lead to an amendment to alter the accrual goal. This consideration will be made independent of arm-specific outcome, in order to eliminate bias

Outcome Time Frame:

Up to 4 years

Safety Issue:


Principal Investigator

Naomi J. Winick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

Related Keywords:

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



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