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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



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