Overview

Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This trial is studying biomarkers to classify young patients with acute lymphoblastic leukemia (ALL) and remission induction therapy in young patients with B-precursor ALL.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Asparaginase
BB 1101
Cytarabine
Daunorubicin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Methotrexate
Pegaspargase
Prednisone
Vincristine
Criteria
DISEASE CHARACTERISTICS:

- 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
contraindication

- ≥ 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
leukemia

- 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.

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

- 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.