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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00003861
Collaborator
National Cancer Institute (NCI) (NIH)
840
51
16.5

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
  • Other: laboratory biomarker analysis

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
840 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Molecular Genetic Features of Acute Leukemia
Study Start Date :
Apr 1, 1999
Anticipated Primary Completion Date :
Jan 1, 2100

Arms and Interventions

Arm Intervention/Treatment
Ancillary-Correlative (molecular genetic features)

Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.

Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

  1. Disease-free survival [At baseline]

  2. Overall survival [At baseline]

  3. Association of novel genes or micorRNAs with other biomarkers [At baseline]

Secondary Outcome Measures

  1. Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [At baseline]

  2. Clinical significance of MRD as defined by W T-1 [At baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003861
Other Study ID Numbers:
  • CALGB-9862
  • U10CA076001
  • CALGB-9862
  • CDR0000067025
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021

Study Results

No Results Posted as of Aug 17, 2021