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ALinC 17, Classification ©), B-precursor Induction Treatment (I)

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Trial Information

ALinC 17, Classification ©), B-precursor Induction Treatment (I)


- To provide the clinical and laboratory data necessary for placing each patient with ALL
onto the proper therapeutic trial. (Classification)

- To provide an administrative base to capture classification data for correlative
studies in ALL treatment protocols and series of historical protocols. (Classification)

- To provide appropriate induction regimens for patients who may then enter risk
specific, post-induction therapeutic trials. (Induction therapy)

- To determine the correlation between event-free survival (EFS) and the following
measures of minimal-residual disease (MRD)/early response (ER): 1) the rate of
peripheral blast count disappearance and the absolute blast count on day 8 as
determined morphologically, by flow cytometry, and using molecular techniques; 2)
Marrow morphology on day 8, and; 3) MRD as determined by flow cytometry and molecular
techniques on bone marrow and peripheral blood samples on day 29. (Induction therapy)

OUTLINE: This is a multicenter study.

- Classification study: Bone marrow or peripheral blood samples are collected and may be
analyzed for B- and T-lineage antigen screening; cytochemical stains; cytogenetics
(karyotype); immunophenotype screening for MLL, E2A-PBX1, TEL-AML1; immunophenotype
detection of minimal-residual disease (MRD); FCM ploidy (DNA index); trisomies 4 and 10
(FISH); molecular testing for BCR/ABL, MLL rearrangements, E2A-PBX1, and TEL-AML1;
molecular detection of MRD - Tγ, Tδ, or IgH; acute lymphoblastic leukemia (ALL) cell
bank; special T-ALL reference laboratory studies (role of tumor suppressor genes in
T-ALL and drug sensitivity profiles in T-ALL); special study for mature B-ALL
[t(18;14)(a24;q32)] by FISH; and hematopathology consultation concerning morphology and
cytochemistry. The immunophenotype results are used to assign patients to a treatment
protocol, to assign patients to post-induction (day 28) risk group and treatment for
patients with B-precursor (non-T, non-B) ALL, and to use as reference laboratory MRD

- Induction therapy study: Patients are entered on stratum 3 (three drugs) for NCI
consensus standard-risk disease (age < 10 years and WBC < 50,000/mm³) or stratum 4
(four drugs) induction therapy for NCI consensus high-risk disease (age ≥ 10 years
and/or WBC ≥ 50,000/mm³ or CNS3 disease or testicular disease).

- Stratum 3: Patients receive oral dexamethasone twice daily on days 1-28;
vincristine sulfate IV on days 1, 8, 15, and 22; pegaspargase intramuscularly (IM)
on day 4, 5, or 6; cytarabine intrathecally (IT) on day 1; and methotrexate IT on
day 8 (some patients also receive methotrexate IT on days 15 and 22).

- Stratum 4: Patients receive oral prednisone twice daily on days 1-28; vincristine
sulfate IV on days 1, 8, 15, and 22; IM SC-PEG E. coli asparaginase IM on days 2,
5, 8, 12, 15, and 19; daunorubicin hydrochloride IV over 15-20 minutes on days 8,
15, and 22; and methotrexate IT on days 1 and 8 (some patients also receive
methotrexate IT on days 15 and 22).

Based on day 29 bone marrow results, patients may start consolidation therapy, undergo
retesting in a week, or receive 2 additional weeks of therapy. Additional therapy comprises
oral prednisone thrice daily for 14 days; vincristine sulfate IV and daunorubicin
hydrochloride IV over 15-20 minutes on days 29 and 36; and IM pegaspargase on day 29, 30, or
31. After successful remission induction, patients are assigned to COG-P9904, COG-P9905, or
COG-P9906 based on the classification study.

Patients undergo bone marrow aspiration on day 8 to determine the prognostic significance of
early remission in the context of this therapy.

After completion of study treatment, patients are followed up every 6 months for 4 years and
annually thereafter.

Inclusion Criteria


- Meets one of the following sets of criteria:

- Classification study:

- Newly diagnosed ALL*

- Must have one of the following:

- ≥ 25% blasts in bone marrow

- ≥ 100,000/μl peripheral blood WBC with ≥ 75% blasts, if bone marrow
aspiration is omitted for any reason other than medical

- ≥ 30,000/μl WBC with ≥ 75% blasts, if bone marrow aspiration is
omitted because of medical contraindication

- Immunophenotype and Wright's stain morphology of blast cells consistent
with acute lymphocytic leukemia

- ≤ 21 years of age at the time of diagnosis

- No previous registration on 9900

- Samples must be sent for local institution and COG Reference Laboratory
studies NOTE: *It is urged that a bone marrow aspiration be performed for
every patient with suspected ALL. However, a marrow is not required for
patients with ≥ 100,000/μl peripheral blood WBC and ≥ 75% blasts or for
those patients whose clinical condition precludes performing the procedure
safely. Patients with a medical contraindication to the procedure must be
discussed with one of the study coordinators and must have a peripheral
blood WBC of ≥ 30,000/μl with ≥ 75% blasts.

- Induction therapy study:

- Patients must have a confirmed diagnosis of B-precursor acute lymphoblastic

- Patients must be 1.001 to 21.999 years at diagnosis NOTE: Patients meeting
all of the above eligibility criteria are eligible for registration on 9900
whether or not they are to be entered on a COG frontline protocol for
treatment of newly diagnosed ALL. Registration on 9900 is required for all
legacy POG institution patients in order to be eligible for entry on the
following COG ALL studies, which are either currently open or only
temporarily closed: P9407, 9904, 9905, 9907, AALL0031 and AALL00P2.


- See Disease Characteristics


- Previously untreated, with the following exception:

- Steroid treatment* in the 48-hour period just prior to study entry will be
allowed provided that a physical examination and CBC with differential were
performed IMMEDIATELY prior to beginning steroids and results of both are known
NOTE: *Patients on chronic steroid treatment for another disease are NOT
eligible for a COG New ALL protocol.

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Collection of the clinical and laboratory data necessary for placing patients with acute lymphoblastic leukemia (ALL) onto the proper therapeutic trial (Classification)

Safety Issue:


Principal Investigator

Dale J. Pullen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Mississippi Cancer Clinic


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma