Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 30
Updated:7/27/2018
Start Date:August 9, 2010

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Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

This research trial studies a risk-based classification system for patients with newly
diagnosed acute lymphoblastic leukemia. Gathering health information about patients with
acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best
treatment.

PRIMARY OBJECTIVES:

I. To provide a risk classification scheme for all patients with newly diagnosed acute
lymphoblastic leukemia (ALL), which will be used to assign treatment on Children?s Oncology
Group (COG) frontline ALL treatment studies.

II. To capture classification data for correlative studies accompanying current COG ALL
treatment protocols.

III. To provide a central reference guide for all required and research studies that will be
conducted in local and reference laboratories for all newly diagnosed ALL patients.

IV. To provide a mechanism for optional banking of leukemia and germline specimens for
current and future research.

OUTLINE:

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and
after induction therapy for immunophenotyping for ALL confirmation and classification,
deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies
4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in
situ hybridization (FISH). Immunophenotype results obtained on this study are used to
determine patient's assignment to specific clinical-trial treatments. Some samples (leukemic
and germline) may be banked for current and/or future analyses.

Inclusion Criteria:

- Patient has newly diagnosed acute leukemia:

- > 25% blasts on a bone marrow (BM) aspirate or

- If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the
diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM
biopsy or

- A complete blood count (CBC) documenting the presence of at least 1,000/uL
circulating leukemic blasts

- Adequate samples must be provided to the reference and/or COG-approved cytogenetics
laboratories to allow completion of the studies needed for risk-stratification

- If a BM aspirate is not performed, or adequate material cannot be obtained,
peripheral blood (PB) can be substituted for BM if there are at least 1,000
circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10%
blasts or a WBC count of 5,000/uL with 20% blasts); if only PB is submitted,
please obtain and send twice the volume of PB as the recommended BM volume
specified; the patient will remain on AALL08B1 as long as all required central
laboratory tests can be successfully performed; as long as there are at least
1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM
samples to make sure that adequate material is available to perform the required
studies

- If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL
PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL
clinical trial (there are NO exceptions to this rule)

- Patient has suspected ALL:

- Patients whose blast morphology is obviously myeloid, or whose blasts are
myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients
with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts
with significant expression of multiple lymphoid and myeloid markers such that
assignment to a single lineage is not possible) are eligible to enroll in
AALL08B1 for cell banking

- Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference
Laboratory studies; if informative results needed for treatment stratification are not
available at specified time-points during induction, patients will not be eligible to
receive post-induction therapy on a COG ALL trial

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA) and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patient must not have received prior cytotoxic therapy except for steroids or
intrathecal chemotherapy

- Patient must not have secondary ALL that developed after treatment of a prior
malignancy with cytotoxic chemotherapy
We found this trial at
215
sites
2545 Schoenersville Rd
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(484) 884-2200
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Phone: 484-884-2201
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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Phone: 505-272-6972
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
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Phone: 214-648-7097
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Alyssa T. Reddy
Phone: 205-975-1941
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666 Elm Street
Buffalo, New York 14263
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Phone: 877-275-7724
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1 South Prospect Street
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802-656-8990
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Phone: 802-656-4101
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1300 Jefferson Park Avenue
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434-243-6784
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Phone: 434-243-6322
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3333 Burnet Avenue # Mlc3008
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 1-513-636-4200 
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Dayton, Ohio 45404
Principal Investigator: Ayman A. El-Sheikh
Phone: 937-641-3296
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Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
Phone: 866-775-6246
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Jeffrey W. Taub
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Hadi Sawaf
Phone: 313-343-3166
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Detroit, MI
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9333 Imperial Highway
Downey, California 90242
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Downey, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Lansing, Michigan 48824
Principal Investigator: Renuka Gera
Phone: 517-975-9547
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East Lansing, MI
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El Paso, Texas 79905
Principal Investigator: Lisa L. Hartman
Phone: 888-823-5923
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801 Broadway North
Fargo, North Dakota 58122
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Fargo, ND
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 239-343-5333
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Kenneth M. Heym
Phone: 682-885-1712
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1600 Southwest Archer Road
Gainesville, Florida 32610
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835 S Van Buren St
Green Bay, Wisconsin 54301
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Green Bay, WI
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: George E. Hucks
Phone: 252-744-2391
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
Principal Investigator: Cary E. Stroud
Phone: 864-241-6251
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