Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00899223
Collaborator
National Cancer Institute (NCI) (NIH)
1,500
Enrollment
142
Locations
10.6
Patients Per Site

Study Details

Study Description

Brief Summary

As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. The highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. There currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. Hence, the patient resources, the health care providers, and a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: biologic sample preservation procedure

Detailed Description

The objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. Buccal smears are obtained at diagnosis, and DNA is extracted and preserved.

It was anticipated that the specimens collected under this protocol would be used by a large number of investigators. This protocol does not describe the details of each approved project (eg, eligibility age range).

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The CALGB Leukemia Tissue Bank
Actual Study Start Date :
May 1, 1996
Anticipated Primary Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Group 1

Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.

Other: biologic sample preservation procedure

Outcome Measures

Primary Outcome Measures

  1. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [At diagnosis]

  2. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [At relapse]

  3. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [At remission]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.

  • Signed informed consent

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Camino Medical Group - Treatment CenterMountain ViewCaliforniaUnited States94040
2Pismo BeachCaliforniaUnited States93449
3Naval Medical Center - San DiegoSan DiegoCaliforniaUnited States92134
4UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCaliforniaUnited States94115
5Helen and Harry Gray Cancer Center at Hartford HospitalHartfordConnecticutUnited States06102-5037
6Tunnell Cancer Center at Beebe Medical CenterLewesDelawareUnited States19958
7CCOP - Christiana Care Health ServicesNewarkDelawareUnited States19713
8Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashingtonDistrict of ColumbiaUnited States20007
9Washington Cancer Institute at Washington Hospital CenterWashingtonDistrict of ColumbiaUnited States20010
10Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort LauderdaleFloridaUnited States33308
11Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiterFloridaUnited States33458
12CCOP - Mount Sinai Medical CenterMiami BeachFloridaUnited States33140
13Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlandoFloridaUnited States32803-1273
14Illinois CancerCare - BloomingtonBloomingtonIllinoisUnited States61701
15St. Joseph Medical CenterBloomingtonIllinoisUnited States61701
16Illinois CancerCare - CantonCantonIllinoisUnited States61520
17University of Illinois Cancer CenterChicagoIllinoisUnited States60612-7243
18Veterans Affairs Medical Center - Chicago Westside HospitalChicagoIllinoisUnited States60612
19University of Chicago Cancer Research CenterChicagoIllinoisUnited States60637-1470
20Eureka Community HospitalEurekaIllinoisUnited States61530
21Illinois CancerCare - EurekaEurekaIllinoisUnited States61530
22Evanston HospitalEvanstonIllinoisUnited States60201-1781
23Galesburg Clinic, PCGalesburgIllinoisUnited States61401
24Illinois CancerCare - MacombMacombIllinoisUnited States61455
25BroMenn Regional Medical CenterNormalIllinoisUnited States61761
26Community Cancer CenterNormalIllinoisUnited States61761
27Illinois CancerCare - Community Cancer CenterNormalIllinoisUnited States61761
28Community Hospital of OttawaOttawaIllinoisUnited States61350
29Oncology Hematology Associates of Central Illinois, PC - OttawaOttawaIllinoisUnited States61350
30Cancer Treatment Center at Pekin HospitalPekinIllinoisUnited States61554
31Illinois CancerCare - PekinPekinIllinoisUnited States61603
32Proctor HospitalPeoriaIllinoisUnited States61614
33CCOP - Illinois Oncology Research AssociationPeoriaIllinoisUnited States61615
34Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoriaIllinoisUnited States61615
35Methodist Medical Center of IllinoisPeoriaIllinoisUnited States61636
36OSF St. Francis Medical CenterPeoriaIllinoisUnited States61637
37Illinois CancerCare - PeruPeruIllinoisUnited States61354
38Illinois Valley Community HospitalPeruIllinoisUnited States61354
39Illinois CancerCare - Spring ValleySpring ValleyIllinoisUnited States61362
40Elkhart Clinic, LLCElkhartIndianaUnited States46514-2098
41Michiana Hematology-Oncology, PC - ElkhartElkhartIndianaUnited States46514
42Elkhart General HospitalElkhartIndianaUnited States46515
43Howard Community HospitalKokomoIndianaUnited States46904
44Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa PorteIndianaUnited States46350
45Suniti Medical CorporationMerrillvilleIndianaUnited States46410
46Michiana Hematology-Oncology, PC - South BendMishawakaIndianaUnited States46545-1470
47Saint Joseph Regional Medical CenterMishawakaIndianaUnited States46545-1470
48Michiana Hematology Oncology PC - PlymouthPlymouthIndianaUnited States46563
49CCOP - Northern Indiana CR ConsortiumSouth BendIndianaUnited States46601
50Memorial Hospital of South BendSouth BendIndianaUnited States46601
51Michiana Hematology Oncology PC - La PorteWestvilleIndianaUnited States46391
52Hematology Oncology Associates of the Quad CitiesBettendorfIowaUnited States52722
53Iowa Blood and Cancer CareCedar RapidsIowaUnited States52402
54Holden Comprehensive Cancer Center at University of IowaIowa CityIowaUnited States52242-1002
55Veterans Affairs Medical Center - Iowa CityIowa CityIowaUnited States52246
56Menorah Medical CenterOverland ParkKansasUnited States66209
57Saint Luke's Hospital - SouthOverland ParkKansasUnited States66213
58CCOP - Kansas CityPrairie VillageKansasUnited States66208
59Harold Alfond Center for Cancer CareAugustaMaineUnited States04330
60CancerCare of Maine at Eastern Maine Medical CenterBangorMaineUnited States04401
61Greenebaum Cancer Center at University of Maryland Medical CenterBaltimoreMarylandUnited States21201
62National Naval Medical CenterBethesdaMarylandUnited States20889-5600
63Union Hospital of Cecil CountyElktonMarylandUnited States21921
64Massachusetts General HospitalBostonMassachusettsUnited States02114
65Dana-Farber/Brigham and Women's Cancer CenterBostonMassachusettsUnited States02115
66Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBostonMassachusettsUnited States02115
67Addison Gilbert HospitalGloucesterMassachusettsUnited States01930
68Lakeland Regional Cancer Care Center - St. JosephSaint JosephMichiganUnited States49085
69Lakeside Cancer Specialists, PLLCSaint JosephMichiganUnited States49085
70St. Luke's Hospital Cancer Care CenterDuluthMinnesotaUnited States55805
71Veterans Affairs Medical Center - MinneapolisMinneapolisMinnesotaUnited States55417
72Masonic Cancer Center at University of MinnesotaMinneapolisMinnesotaUnited States55455
73Southeast Cancer CenterCape GirardeauMissouriUnited States63703
74Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbiaMissouriUnited States65203
75Goldschmidt Cancer CenterJefferson CityMissouriUnited States65109
76Saint Luke's Cancer Institute at Saint Luke's HospitalKansas CityMissouriUnited States64111
77North Kansas City HospitalKansas CityMissouriUnited States64116
78Heartland Hematology Oncology Associates, IncorporatedKansas CityMissouriUnited States64118
79Research Medical CenterKansas CityMissouriUnited States64132
80Saint Luke's East - Lee's SummitLee's SummitMissouriUnited States64086
81Saint Joseph Oncology, IncorporatedSaint JosephMissouriUnited States64507
82Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSaint LouisMissouriUnited States63110
83Missouri Baptist Cancer CenterSaint LouisMissouriUnited States63131
84Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand IslandNebraskaUnited States68803
85Callahan Cancer Center at Great Plains Regional Medical CenterNorth PlatteNebraskaUnited States69103
86UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmahaNebraskaUnited States68198-6805
87University Medical Center of Southern NevadaLas VegasNevadaUnited States89102
88CCOP - Nevada Cancer Research FoundationLas VegasNevadaUnited States89106
89Sunrise Hospital and Medical CenterLas VegasNevadaUnited States89109
90New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcordNew HampshireUnited States03301
91New Hampshire Oncology - Hematology, PA - HooksettHooksettNew HampshireUnited States03106
92Lakes Region General HospitalLaconiaNew HampshireUnited States03246
93Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanonNew HampshireUnited States03756-0002
94Norris Cotton Cancer Center at Catholic Medical CenterManchesterNew HampshireUnited States03102
95Cancer Institute of New Jersey at Cooper - VoorheesVoorheesNew JerseyUnited States08043
96Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263-0001
97CCOP - Hematology-Oncology Associates of Central New YorkEast SyracuseNew YorkUnited States13057
98Charles R. Wood Cancer Center at Glens Falls HospitalGlens FallsNew YorkUnited States12801
99Queens Cancer Center of Queens HospitalJamaicaNew YorkUnited States11432
100Monter Cancer Center of the North Shore-LIJ Health SystemLake SuccessNew YorkUnited States11042
101CCOP - North Shore University HospitalManhassetNew YorkUnited States11030
102Don Monti Comprehensive Cancer Center at North Shore University HospitalManhassetNew YorkUnited States11030
103Long Island Jewish Medical CenterNew Hyde ParkNew YorkUnited States11040
104New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew YorkUnited States10021
105Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
106SUNY Upstate Medical University HospitalSyracuseNew YorkUnited States13210
107Veterans Affairs Medical Center - SyracuseSyracuseNew YorkUnited States13210
108Mission Hospitals - Memorial CampusAshevilleNorth CarolinaUnited States28801
109Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth CarolinaUnited States27599-7295
110Blumenthal Cancer Center at Carolinas Medical CenterCharlotteNorth CarolinaUnited States28232-2861
111Presbyterian Cancer Center at Presbyterian HospitalCharlotteNorth CarolinaUnited States28233-3549
112Batte Cancer Center at Northeast Medical CenterConcordNorth CarolinaUnited States28025
113Duke Cancer InstituteDurhamNorth CarolinaUnited States27710
114Wayne Memorial Hospital, IncorporatedGoldsboroNorth CarolinaUnited States27534
115Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenvilleNorth CarolinaUnited States27834
116Pardee Memorial HospitalHendersonvilleNorth CarolinaUnited States28791
117Kinston Medical SpecialistsKinstonNorth CarolinaUnited States28501
118Cleveland Regional Medical CenterShelbyNorth CarolinaUnited States28150
119Iredell Memorial HospitalStatesvilleNorth CarolinaUnited States28677
120Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-SalemNorth CarolinaUnited States27103
121Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth CarolinaUnited States27157-1096
122Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbusOhioUnited States43210-1240
123Cancer Care Associates - NormanNormanOklahomaUnited States73071
124Oklahoma University Cancer InstituteOklahoma CityOklahomaUnited States73104
125Cancer Care Associates - Mercy CampusOklahoma CityOklahomaUnited States73120
126Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburghPennsylvaniaUnited States15224-1791
127Rhode Island Hospital Comprehensive Cancer CenterProvidenceRhode IslandUnited States02903
128Miriam HospitalProvidenceRhode IslandUnited States02906
129McLeod Regional Medical CenterFlorenceSouth CarolinaUnited States29501
130Cancer Centers of the Carolinas - Faris RoadGreenvilleSouth CarolinaUnited States29605
131Cancer Centers of the Carolinas - Grove CommonsGreenvilleSouth CarolinaUnited States29605
132Greenville Hospital Cancer CenterGreenvilleSouth CarolinaUnited States29605
133Cancer Centers of the Carolinas - EastsideGreenvilleSouth CarolinaUnited States29615
134CCOP - GreenvilleGreenvilleSouth CarolinaUnited States29615
135Cancer Centers of the Carolinas - Greer Medical OncologyGreerSouth CarolinaUnited States29650
136Cancer Centers of the Carolinas - SenecaSenecaSouth CarolinaUnited States29672
137Cancer Centers of the Carolinas - SpartanburgSpartanburgSouth CarolinaUnited States29307
138Mountainview MedicalBerlinVermontUnited States05602
139Fletcher Allen Health Care - University Health Center CampusBurlingtonVermontUnited States05401
140Danville Regional Medical CenterDanvilleVirginiaUnited States24541
141Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsvilleVirginiaUnited States24115
142Virginia Commonwealth University Massey Cancer CenterRichmondVirginiaUnited States23298-0037

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Caligiuri, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00899223
Other Study ID Numbers:
  • CALGB-9665
  • U10CA031946
  • CALGB-9665
  • CDR0000271412
First Posted:
May 12, 2009
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021