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
142
10.6

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 Disease Intervention/Treatment Phase
  • 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, 2022

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Camino Medical Group - Treatment Center Mountain View California United States 94040
2 Pismo Beach California United States 93449
3 Naval Medical Center - San Diego San Diego California United States 92134
4 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94115
5 Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut United States 06102-5037
6 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
7 CCOP - Christiana Care Health Services Newark Delaware United States 19713
8 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20007
9 Washington Cancer Institute at Washington Hospital Center Washington District of Columbia United States 20010
10 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida United States 33308
11 Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida United States 33458
12 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
13 Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida United States 32803-1273
14 Illinois CancerCare - Bloomington Bloomington Illinois United States 61701
15 St. Joseph Medical Center Bloomington Illinois United States 61701
16 Illinois CancerCare - Canton Canton Illinois United States 61520
17 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
18 Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois United States 60612
19 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
20 Eureka Community Hospital Eureka Illinois United States 61530
21 Illinois CancerCare - Eureka Eureka Illinois United States 61530
22 Evanston Hospital Evanston Illinois United States 60201-1781
23 Galesburg Clinic, PC Galesburg Illinois United States 61401
24 Illinois CancerCare - Macomb Macomb Illinois United States 61455
25 BroMenn Regional Medical Center Normal Illinois United States 61761
26 Community Cancer Center Normal Illinois United States 61761
27 Illinois CancerCare - Community Cancer Center Normal Illinois United States 61761
28 Community Hospital of Ottawa Ottawa Illinois United States 61350
29 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
30 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
31 Illinois CancerCare - Pekin Pekin Illinois United States 61603
32 Proctor Hospital Peoria Illinois United States 61614
33 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
34 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
35 Methodist Medical Center of Illinois Peoria Illinois United States 61636
36 OSF St. Francis Medical Center Peoria Illinois United States 61637
37 Illinois CancerCare - Peru Peru Illinois United States 61354
38 Illinois Valley Community Hospital Peru Illinois United States 61354
39 Illinois CancerCare - Spring Valley Spring Valley Illinois United States 61362
40 Elkhart Clinic, LLC Elkhart Indiana United States 46514-2098
41 Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana United States 46514
42 Elkhart General Hospital Elkhart Indiana United States 46515
43 Howard Community Hospital Kokomo Indiana United States 46904
44 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
45 Suniti Medical Corporation Merrillville Indiana United States 46410
46 Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana United States 46545-1470
47 Saint Joseph Regional Medical Center Mishawaka Indiana United States 46545-1470
48 Michiana Hematology Oncology PC - Plymouth Plymouth Indiana United States 46563
49 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
50 Memorial Hospital of South Bend South Bend Indiana United States 46601
51 Michiana Hematology Oncology PC - La Porte Westville Indiana United States 46391
52 Hematology Oncology Associates of the Quad Cities Bettendorf Iowa United States 52722
53 Iowa Blood and Cancer Care Cedar Rapids Iowa United States 52402
54 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
55 Veterans Affairs Medical Center - Iowa City Iowa City Iowa United States 52246
56 Menorah Medical Center Overland Park Kansas United States 66209
57 Saint Luke's Hospital - South Overland Park Kansas United States 66213
58 CCOP - Kansas City Prairie Village Kansas United States 66208
59 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
60 CancerCare of Maine at Eastern Maine Medical Center Bangor Maine United States 04401
61 Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland United States 21201
62 National Naval Medical Center Bethesda Maryland United States 20889-5600
63 Union Hospital of Cecil County Elkton Maryland United States 21921
64 Massachusetts General Hospital Boston Massachusetts United States 02114
65 Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts United States 02115
66 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts United States 02115
67 Addison Gilbert Hospital Gloucester Massachusetts United States 01930
68 Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan United States 49085
69 Lakeside Cancer Specialists, PLLC Saint Joseph Michigan United States 49085
70 St. Luke's Hospital Cancer Care Center Duluth Minnesota United States 55805
71 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
72 Masonic Cancer Center at University of Minnesota Minneapolis Minnesota United States 55455
73 Southeast Cancer Center Cape Girardeau Missouri United States 63703
74 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
75 Goldschmidt Cancer Center Jefferson City Missouri United States 65109
76 Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri United States 64111
77 North Kansas City Hospital Kansas City Missouri United States 64116
78 Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri United States 64118
79 Research Medical Center Kansas City Missouri United States 64132
80 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
81 Saint Joseph Oncology, Incorporated Saint Joseph Missouri United States 64507
82 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri United States 63110
83 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
84 Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska United States 68803
85 Callahan Cancer Center at Great Plains Regional Medical Center North Platte Nebraska United States 69103
86 UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska United States 68198-6805
87 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
88 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
89 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
90 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire United States 03301
91 New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire United States 03106
92 Lakes Region General Hospital Laconia New Hampshire United States 03246
93 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
94 Norris Cotton Cancer Center at Catholic Medical Center Manchester New Hampshire United States 03102
95 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
96 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
97 CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York United States 13057
98 Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York United States 12801
99 Queens Cancer Center of Queens Hospital Jamaica New York United States 11432
100 Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York United States 11042
101 CCOP - North Shore University Hospital Manhasset New York United States 11030
102 Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York United States 11030
103 Long Island Jewish Medical Center New Hyde Park New York United States 11040
104 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
105 Mount Sinai Medical Center New York New York United States 10029
106 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
107 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
108 Mission Hospitals - Memorial Campus Asheville North Carolina United States 28801
109 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
110 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
111 Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina United States 28233-3549
112 Batte Cancer Center at Northeast Medical Center Concord North Carolina United States 28025
113 Duke Cancer Institute Durham North Carolina United States 27710
114 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
115 Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina United States 27834
116 Pardee Memorial Hospital Hendersonville North Carolina United States 28791
117 Kinston Medical Specialists Kinston North Carolina United States 28501
118 Cleveland Regional Medical Center Shelby North Carolina United States 28150
119 Iredell Memorial Hospital Statesville North Carolina United States 28677
120 Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina United States 27103
121 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
122 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210-1240
123 Cancer Care Associates - Norman Norman Oklahoma United States 73071
124 Oklahoma University Cancer Institute Oklahoma City Oklahoma United States 73104
125 Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma United States 73120
126 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224-1791
127 Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island United States 02903
128 Miriam Hospital Providence Rhode Island United States 02906
129 McLeod Regional Medical Center Florence South Carolina United States 29501
130 Cancer Centers of the Carolinas - Faris Road Greenville South Carolina United States 29605
131 Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina United States 29605
132 Greenville Hospital Cancer Center Greenville South Carolina United States 29605
133 Cancer Centers of the Carolinas - Eastside Greenville South Carolina United States 29615
134 CCOP - Greenville Greenville South Carolina United States 29615
135 Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina United States 29650
136 Cancer Centers of the Carolinas - Seneca Seneca South Carolina United States 29672
137 Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina United States 29307
138 Mountainview Medical Berlin Vermont United States 05602
139 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
140 Danville Regional Medical Center Danville Virginia United States 24541
141 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville Virginia United States 24115
142 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: 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:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022