Study of Bone Marrow and Blood Samples in Patients With Untreated Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Enrolled on Clinical Trial CALGB-9621 or CALGB-9720

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT01004965

Collaborator

National Cancer Institute (NCI) (NIH)

2,034

Enrollment

Locations

159

Actual Duration (Months)

44.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is looking at bone marrow and blood samples in patients with untreated acute myeloid leukemia or acute lymphoblastic leukemia enrolled on clinical trial CALGB-9621, CALGB-9720, CALGB 19808, and CALGB 10201. Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

Determine Pgp antigen expression and Pgp-mediated functional multidrug resistance (MDR) in pretreatment acute myeloid leukemia (AML) cells from adult patients enrolled on CALGB clinical trials of PSC-833 Pgp modulation.
Correlate Pgp-mediated MDR with patient pretreatment characteristics including age, immunophenotype, and karyotype.
Correlate Pgp expression, function, and in vitro modulation by PSC-833 with treatment outcome in previously untreated AML patients treated on CALGB Pgp modulation trials.
Determine Pgp expression and function in AML cells from patients with refractory or relapsed leukemia following induction chemotherapy administered with or without PSC-833.
Correlate acquisition of drug resistance with changes in expression of other antigens and gain or loss of leukemic populations at relapse in these patients.
Determine the role of other mediators, including multidrug resistance-associated protein (MRP) and lung-resistance protein (LRP), in mediating MDR in these patients at diagnosis and with relapsed or refractory disease after induction chemotherapy with or without PSC-833.
Determine the frequency of Pgp-, MRP-, and LRP- mediated MDR in adult acute lymphoblastic leukemia cells and correlate this frequency with pretreatment characteristics and treatment outcome in these patients.

OUTLINE:

Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts. Pgp expression is measured using flow cytometry. AML samples are analyzed by immunoenzyme techniques (IET) using antibodies to CD33, CD34, and MRK16. B-lineage acute lymphoblastic leukemia (ALL) samples are analyzed by IET using antibodies to CD19, CD34, and MRK16. The antibodies used to analyze T-cells include CD7 and CD34. Pgp function is measured by growing cells in the presence of PSC-833 in vitro and then measuring Pgp expression as above. Multidrug resistance-associated protein (MRP) is measured using IET with the MRPm6 antibody. Lung-resistance protein (LRP) is measured with IET and the LRP56 antibody. These results are correlated with flow cytometry results.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2034 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multidrug Resistance Studies in Acute Myeloid Leukemia

Actual Study Start Date :

Mar 15, 1997

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jun 16, 2010

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Samples are obtained: 1) pretreatment, 2) at the time of documentation of refractory disease in acute myeloid leukemia (AML) patients who do not achieve complete response (CR) after induction therapy, and 3) at the time of first relapse in patients who achieve CR. Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts.	Other: laboratory biomarker analysis

Arm

Intervention/Treatment

Group 1

Samples are obtained: 1) pretreatment, 2) at the time of documentation of refractory disease in acute myeloid leukemia (AML) patients who do not achieve complete response (CR) after induction therapy, and 3) at the time of first relapse in patients who achieve CR. Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts.

Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

completion rate [Up to 5 years]

Secondary Outcome Measures

duration of completion rate [Up to 5 years]
survival [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Previously untreated patients eligible for and registered to a CALGB multidrug resistance modulation treatment protocol for acute myeloid leukemia (CALGB 9621, CALGB-9720, CALGB-19808, and CALGB 10201) OR protocols for previously untreated acute lymphocytic leukemia
Performance status: not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center - San Diego	San Diego	California	United States	92134
2	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
3	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
4	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
5	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
6	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
7	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
8	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
9	Menorah Medical Center	Overland Park	Kansas	United States	66209
10	Saint Luke's Hospital - South	Overland Park	Kansas	United States	66213
11	Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
12	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine	United States	04401
13	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
14	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
15	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
16	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
17	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
18	North Kansas City Hospital	Kansas City	Missouri	United States	64116
19	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
20	CCOP - Kansas City	Kansas City	Missouri	United States	64131
21	Research Medical Center	Kansas City	Missouri	United States	64132
22	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
23	Liberty Hospital	Liberty	Missouri	United States	64068
24	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
25	Saint Joseph Oncology, Incorporated	Saint Joseph	Missouri	United States	64507
26	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
27	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
28	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
29	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
30	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
31	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
32	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
33	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
34	Monter Cancer Center of the North Shore-LIJ Health System	Lake Success	New York	United States	11042
35	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
36	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York	United States	11030
37	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
38	Mount Sinai Medical Center	New York	New York	United States	10029
39	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
40	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
41	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
42	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
43	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
44	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
45	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island	United States	02860
46	McLeod Regional Medical Center	Florence	South Carolina	United States	29501