Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Objectives:
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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.
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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.
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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.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Ancillary-Correlative (molecular genetic features) Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry. |
Other: laboratory biomarker analysis
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Outcome Measures
Primary Outcome Measures
- Disease-free survival [At baseline]
- Overall survival [At baseline]
- Association of novel genes or micorRNAs with other biomarkers [At baseline]
Secondary Outcome Measures
- Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [At baseline]
- Clinical significance of MRD as defined by W T-1 [At baseline]
Eligibility Criteria
Criteria
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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.
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Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Naval Medical Center - San Diego | San Diego | California | United States | 92134 |
2 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
3 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
4 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
5 | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | United States | 32803-1273 |
6 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
7 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
8 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
9 | Harold Alfond Center for Cancer Care | Augusta | Maine | United States | 04330 |
10 | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
11 | Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | United States | 04074 |
12 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
13 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
14 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
15 | Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | United States | 02115 |
16 | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
17 | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
18 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
19 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
20 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
21 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
22 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
23 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
24 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
25 | Queens Cancer Center of Queens Hospital | Jamaica | New York | United States | 11432 |
26 | Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | United States | 11042 |
27 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
28 | Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | United States | 11030 |
29 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
30 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
31 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
32 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
33 | Veterans Affairs Medical Center - Syracuse | Syracuse | New York | United States | 13210 |
34 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7295 |
35 | Duke Cancer Institute | Durham | North Carolina | United States | 27710 |
36 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
37 | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | United States | 27834 |
38 | Kinston Medical Specialists | Kinston | North Carolina | United States | 28501 |
39 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
40 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
41 | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224-1791 |
42 | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | United States | 02903 |
43 | Miriam Hospital | Providence | Rhode Island | United States | 02906 |
44 | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | United States | 29605 |
45 | Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | United States | 29605 |
46 | Greenville Hospital Cancer Center | Greenville | South Carolina | United States | 29605 |
47 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
48 | Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | United States | 29650 |
49 | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | United States | 29672 |
50 | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | United States | 29307 |
51 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Wendy Stock, MD, University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-9862
- U10CA076001
- CALGB-9862
- CDR0000067025