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Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay


N/A
18 Years
N/A
Not Enrolling
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts

Thank you

Trial Information

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay


PRIMARY OBJECTIVES:

I. To obtain results from a high throughput drug sensitivity assay within 10 days, procure
drug within 14 days and initiate treatment within 21 days.

SECONDARY OBJECTIVES:

I. To achieve a response (cytoreduction or at least partial response) greater that than
expected for comparable refractory patient populations with other salvage regimens.

OUTLINE:

Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity
assay.

After completion of study treatment, patients are followed every 3 months for 2 years.


Inclusion Criteria:



- Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria
(except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia
with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative
neoplasm with >= 10% blasts in the bone marrow or peripheral blood, including
chronic myelomonocytic leukemia (CMML)-2 by WHO classification who have failed 2
inductions at initial diagnosis or failed 2 salvage regimens for relapsed AML with
duration of 1st remission of less than 1 year

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3

- Expectation that we can obtain about 100 million blasts from blood and/or marrow (for
example, circulating blast count of 5,000 or greater)

- Bilirubin =< 1 .5 x institutional upper limit of normal (IULN) unless elevation is
thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the
hematologic malignancy

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum pyruvate glutamate transaminase (SPGT) (alanine aminotransferase [ALT]) =< 2.5
x IULN, unless elevation in thought to be due to hepatic infiltration by the
hematologic malignancy

- Alkaline phosphatase =< 2.5 X ULN

- Serum creatinine =< 2.0 mg/dL

- Stable or improving on appropriate antimicrobial therapy for infection, without
ongoing fever

- Informed consent

- Willing to use contraception

Exclusion Criteria:

- No other concomitant treatment for leukemia

- No other active cancer that requires systemic chemotherapy or radiation

- Significant organ compromise that will increase risk of toxicity or mortality

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility defined as results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days

Outcome Time Frame:

Up to 21 days

Safety Issue:

No

Principal Investigator

Pamela Becker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

8003

NCT ID:

NCT01872819

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Chronic Myelomonocytic Leukemia
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109