Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

Basic Trial Information

Objectives

1. 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).
2. 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 outcome.
3. 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.
4. Compare the measurement of MRD in blood with bone marrow specimens in sequential remission specimens.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

Age:

• Adult

Performance status:

• See Disease Characteristics

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• See Disease Characteristics

Hepatic:

• See Disease Characteristics

Renal:

• See Disease Characteristics

Expected Enrollment

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

Outcomes

Disease-free survival
Overall survival

Association of novel genes or micorRNAs with other biomarkers
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL
Clinical significance of MRD as defined by W T-1
Blood and bone marrow specimen comparison on the quantitative measurement of MRD

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Wendy Stock, MD, Protocol chair		Ph: 773-834-8982; 888-824-0200

U.S.A.
California
	San Diego
	Naval Medical Center - San Diego
		Preston Gable, MD, FACP	Ph:  619-532-7319
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Florida
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Maine
	Augusta
	Harold Alfond Center for Cancer Care
		Thomas Openshaw	Ph:  207-621-6100 800-593-4024
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
	Scarborough
	Maine Center for Cancer Medicine and Blood Disorders - Scarborough
		Helen Ryan	Ph:  207-885-7600
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Bethesda
	National Naval Medical Center
		David Van Echo	Ph:  301-295-5706
	Elkton MD
	Union Hospital of Cecil County
		Stephen Grubbs, MD	Ph:  302-366-1200
Massachusetts
	Boston
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Richard Stone, MD	Ph:  617-632-2214
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Geoffrey Uy	Ph:  314-747-7222 800-600-3606
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-384-0013
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Lake Success
	Monter Cancer Center of the North Shore-LIJ Health System
		Jonathan Kolitz, MD	Ph:  516-562-8970
	Manhasset
	CCOP - North Shore University Hospital
		Jonathan Kolitz, MD	Ph:  516-562-8970
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	New Hyde Park
	Long Island Jewish Medical Center
		Jonathan Kolitz, MD	Ph:  516-562-8970
	New York
	Mount Sinai Medical Center
		Lewis Silverman, MD	Ph:  212-241-5520
	New York Weill Cornell Cancer Center at Cornell University
		Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University	Ph:  212-746-1848
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Veterans Affairs Medical Center - Syracuse
		Jane Hudson	Ph:  315-425-4400 800-792-4334
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School	Ph:  252-744-2391
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
Pennsylvania
	Pittsburgh
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		John Lister	Ph:  412-578-5000
Rhode Island
	Providence
	Miriam Hospital
		Clinical Trials Office - Miriam Hospital	Ph:  401-793-2224
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Suzanne Fanning	Ph:  864-679-3900
	Cancer Centers of the Carolinas - Grove Commons
		Clinical Trials Office - Cancer Centers of the Carolinas	Ph:  864-241-6251
	CCOP - Greenville
		Suzanne Fanning	Ph:  864-241-6251
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
	Greenwood
	Self Regional Cancer Center at Self Regional Medical Center
		Suzanne Fanning	Ph:  864-330-7100
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Suzanne Fanning	Ph:  864-662-4000
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Suzanne Fanning	Ph:  864-888-3717
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Suzanne Fanning	Ph:  864-699-5700
Vermont
	Berlin
	Mountainview Medical
		Barbara Grant, MD	Ph:  802-847-8400
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939

Related Information

PDQ® clinical trial CDR0000066807
PDQ® clinical trial SWOG-S0521
PDQ® clinical trial SWOG-S0535

Registry Information
Official Title		Molecular Genetic Features of Acute Lymphoblastic Leukemia
Trial Start Date		1999-04-15
Registered in ClinicalTrials.gov		NCT00003861
Date Submitted to PDQ		1999-04-14
Information Last Verified		2012-01-27
NCI Grant/Contract Number		CA76001

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