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Molecular Genetic Features of Acute Lymphoblastic Leukemia

18 Years
Open (Enrolling)

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Trial Information

Molecular Genetic Features of Acute Lymphoblastic Leukemia


- Perform quantitative polymerase chain reaction (PCR) using known leukemia specific
markers in diagnostic bone marrow specimens and correlate pre-treatment copy number
with other biologic and molecular features, clinical response, and treatment outcomes
of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute
promyelocytic leukemia (APL).

- Evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis
and treatment response in pretreatment blood and bone marrow specimens of these
patients and correlate these findings with other biological features and treatment

- Evaluate the clinical significance of sequential quantitative MRD measurements using
real-time quantitative PCR and/or flow cytometry during and following treatment and
correlate these findings with efficacy of novel treatment approaches and other
biological and clinical prognostic features.

- Compare the measurement of MRD in blood with bone marrow specimens in sequential
remission specimens.

OUTLINE: Blood and bone marrow samples are collected from patients periodically.

Samples are examined for the p190 and p210 BCR-ABL and WT-1 transcripts using reverse
transcriptase-polymerase chain reaction (RT-PCR) analysis of the DNA and for marginal
residual disease (MRD) via flow cytometric analysis.

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study over 5 years.

Inclusion Criteria


- Diagnosis of 1 of the following diseases:

- Acute lymphoblastic leukemia (ALL)

- Patients enrolled on CALGB-19802 or any CALGB treatment trials for
previously untreated ALL, must be enrolled on this trial

- Acute promyelocytic leukemia (APL)

- Patients enrolled on SWOG-S0521 or SWOG-S0535 for previously untreated APL
must be enrolled on this trial



- Adult

Performance status:

- See Disease Characteristics

Life expectancy:

- See Disease Characteristics


- See Disease Characteristics


- See Disease Characteristics


- See Disease Characteristics


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Wendy Stock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago



Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute lymphoblastic leukemia
  • adult acute promyelocytic leukemia (M3)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Promyelocytic, Acute



Roswell Park Cancer InstituteBuffalo, New York  14263
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - GreenvilleGreenville, South Carolina  29615
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Duke Cancer InstituteDurham, North Carolina  27710
Kinston Medical SpecialistsKinston, North Carolina  28501
Miriam HospitalProvidence, Rhode Island  02906
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307