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Clinical Trials (PDQ®)
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Last Modified: 11/11/2009     First Published: 9/1/1999  
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Molecular Monitoring Study in Adults With Previously Untreated Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

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

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnosticActiveAdultNCICALGB-9862
NCT00003861

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

450

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

Outcomes

Primary Outcome(s)

Disease-free survival
Overall survival

Secondary Outcome(s)

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

Trial Sites

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: 302-733-6227
District of Columbia
  Washington
 Walter Reed Army Medical Center
 Clinical Trials Office - Walter Reed Army Medical Center
Ph: 202-782-7840
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
Illinois
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3605
  Canton
 Graham Hospital
 John Kugler, MD
Ph: 309-243-3605
  Carthage
 Memorial Hospital
 John Kugler, MD
Ph: 309-243-3605
  Chicago
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
 University of Illinois Cancer Center
 Clinical Trial Office - University of Illinois Cancer Center
Ph: 312-355-3046
  Eureka
 Eureka Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Galesburg
 Galesburg Clinic, PC
 John Kugler, MD
Ph: 309-243-3605
 Galesburg Cottage Hospital
 John Kugler, MD
Ph: 309-243-3605
  Havana
 Mason District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Macomb
 McDonough District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3605
  Ottawa
 Community Hospital of Ottawa
 John Kugler, MD
Ph: 309-243-3605
 Oncology Hematology Associates of Central Illinois, PC - Ottawa
 John Kugler, MD
Ph: 309-243-3605
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3605
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3605
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Proctor Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peru
 Illinois Valley Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Spring Valley
 St. Margaret's Hospital
 John Kugler, MD
Ph: 309-243-3605
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
  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
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 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
 Missouri Cancer Associates
 Clinical Trials Office - Missouri Cancer Associates
Ph: 866-724-2413
 Email: research@missouricancer.com
  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 Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
 Email: cancerhelp@dartmouth.edu
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
 Leslie Howard, MD
Ph: 315-425-3456
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 Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
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 Solove Research Institute at Ohio State University Medical 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
 Rhode Island Hospital Comprehensive Cancer Center
 Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center
Ph: 401-444-1488
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 CLB-19802
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 2009-11-11
NCI Grant/Contract Number CA76001

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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