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NCT00003861 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Molecular Genetic Features of Acute Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00003861
Other study ID # CALGB-9862
Secondary ID U10CA076001CALGB
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1999

Study information
Verified date August 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 840
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on CALGB 8461 is strongly encouraged. - Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis

Locations
Country Name City State
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
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 Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Duke Cancer Institute Durham North Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Union Hospital of Cecil County Elkton Maryland
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States Kinston Medical Specialists Kinston North Carolina
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Long Island Jewish Medical Center New Hyde Park New York
United States Mount Sinai Medical Center New York New York
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Naval Medical Center - San Diego San Diego California
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough Maine
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free survival At baseline
Primary Overall survival At baseline
Primary Association of novel genes or micorRNAs with other biomarkers At baseline
Secondary Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL At baseline
Secondary Clinical significance of MRD as defined by W T-1 At baseline
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