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Multidrug Resistance Studies in Acute Myeloid Leukemia

18 Years
Open (Enrolling)

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Trial Information

Multidrug Resistance Studies in Acute Myeloid Leukemia


- 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

- 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: 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.

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.

PROJECTED ACCRUAL: Approximately 2034 patients will be accrued for this study over 5 years.

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


- Not specified

Type of Study:


Study Design:


Outcome Measure:

Expression and function of the multidrug resistance (MDR) mediators, other patient variables (immunophenotype, karyotype, demographic variables, and other characteristics), treatment, and outcome (CR rate, duration of CR, survival)

Safety Issue:


Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Roswell Park Cancer Institute Buffalo, New York  14263
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - North Shore University Hospital Manhasset, New York  11030
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Naval Medical Center - San Diego San Diego, California  92134-3202
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Long Island Jewish Medical Center New Hyde Park, New York  11040
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
University of Illinois Cancer Center Chicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860
Kinston Medical Specialists Kinston, North Carolina  28501
McLeod Regional Medical Center Florence, South Carolina  29501