Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
- Conditions
- LeukemiaAcute Lymphoblastic LeukemiaAcute Promyelocytic Leukemia
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT00003861
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
- Detailed Description
Objectives:
1. To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
2. To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
3. To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
4. To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 840
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (molecular genetic features) laboratory biomarker analysis Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.
- Primary Outcome Measures
Name Time Method Disease-free survival At baseline Overall survival At baseline Association of novel genes or micorRNAs with other biomarkers At baseline
- Secondary Outcome Measures
Name Time Method Clinical significance of MRD as defined by W T-1 At baseline Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL At baseline
Trial Locations
- Locations (51)
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber/Brigham and Women's Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CancerCare of Maine at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
Harold Alfond Center for Cancer Care
🇺🇸Augusta, Maine, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
🇺🇸Lake Success, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
🇺🇸Manhasset, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Cancer Centers of the Carolinas - Grove Commons
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸Greenville, South Carolina, United States
Greenville Hospital Cancer Center
🇺🇸Greenville, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States