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Multidrug Resistance Studies in Acute Myeloid Leukemia


N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Multidrug Resistance Studies in Acute Myeloid Leukemia


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: 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Performance status: not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

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:

No

Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000078568

NCT ID:

NCT01004965

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860
Kinston Medical SpecialistsKinston, North Carolina  28501
McLeod Regional Medical CenterFlorence, South Carolina  29501