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
Enrollment
51
Locations
16.5
Patients Per Site

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Naval Medical Center - San DiegoSan DiegoCaliforniaUnited States92134
2UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCaliforniaUnited States94115
3Tunnell Cancer Center at Beebe Medical CenterLewesDelawareUnited States19958
4CCOP - Christiana Care Health ServicesNewarkDelawareUnited States19713
5Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlandoFloridaUnited States32803-1273
6University of Illinois Cancer CenterChicagoIllinoisUnited States60612-7243
7University of Chicago Cancer Research CenterChicagoIllinoisUnited States60637-1470
8Holden Comprehensive Cancer Center at University of IowaIowa CityIowaUnited States52242-1002
9Harold Alfond Center for Cancer CareAugustaMaineUnited States04330
10CancerCare of Maine at Eastern Maine Medical CenterBangorMaineUnited States04401
11Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarboroughMaineUnited States04074
12Greenebaum Cancer Center at University of Maryland Medical CenterBaltimoreMarylandUnited States21201
13Union Hospital of Cecil CountyElktonMarylandUnited States21921
14Massachusetts General HospitalBostonMassachusettsUnited States02114
15Dana-Farber/Brigham and Women's Cancer CenterBostonMassachusettsUnited States02115
16Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBostonMassachusettsUnited States02115
17Masonic Cancer Center at University of MinnesotaMinneapolisMinnesotaUnited States55455
18Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbiaMissouriUnited States65203
19Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSaint LouisMissouriUnited States63110
20University Medical Center of Southern NevadaLas VegasNevadaUnited States89102
21CCOP - Nevada Cancer Research FoundationLas VegasNevadaUnited States89106
22Cancer Institute of New Jersey at Cooper - VoorheesVoorheesNew JerseyUnited States08043
23Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263-0001
24CCOP - Hematology-Oncology Associates of Central New YorkEast SyracuseNew YorkUnited States13057
25Queens Cancer Center of Queens HospitalJamaicaNew YorkUnited States11432
26Monter Cancer Center of the North Shore-LIJ Health SystemLake SuccessNew YorkUnited States11042
27CCOP - North Shore University HospitalManhassetNew YorkUnited States11030
28Don Monti Comprehensive Cancer Center at North Shore University HospitalManhassetNew YorkUnited States11030
29Long Island Jewish Medical CenterNew Hyde ParkNew YorkUnited States11040
30New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew YorkUnited States10021
31Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
32SUNY Upstate Medical University HospitalSyracuseNew YorkUnited States13210
33Veterans Affairs Medical Center - SyracuseSyracuseNew YorkUnited States13210
34Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth CarolinaUnited States27599-7295
35Duke Cancer InstituteDurhamNorth CarolinaUnited States27710
36Wayne Memorial Hospital, IncorporatedGoldsboroNorth CarolinaUnited States27534
37Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenvilleNorth CarolinaUnited States27834
38Kinston Medical SpecialistsKinstonNorth CarolinaUnited States28501
39Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth CarolinaUnited States27157-1096
40Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbusOhioUnited States43210-1240
41Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburghPennsylvaniaUnited States15224-1791
42Rhode Island Hospital Comprehensive Cancer CenterProvidenceRhode IslandUnited States02903
43Miriam HospitalProvidenceRhode IslandUnited States02906
44Cancer Centers of the Carolinas - Faris RoadGreenvilleSouth CarolinaUnited States29605
45Cancer Centers of the Carolinas - Grove CommonsGreenvilleSouth CarolinaUnited States29605
46Greenville Hospital Cancer CenterGreenvilleSouth CarolinaUnited States29605
47CCOP - GreenvilleGreenvilleSouth CarolinaUnited States29615
48Cancer Centers of the Carolinas - Greer Medical OncologyGreerSouth CarolinaUnited States29650
49Cancer Centers of the Carolinas - SenecaSenecaSouth CarolinaUnited States29672
50Cancer Centers of the Carolinas - SpartanburgSpartanburgSouth CarolinaUnited States29307
51Virginia Commonwealth University Massey Cancer CenterRichmondVirginiaUnited States23298-0037

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